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510(k) K012715

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II by Hygia Health Services, Inc. — Product Code NLF

K012715 is an FDA 510(k) premarket notification submitted by Hygia Health Services, Inc. for the device "HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II". The FDA issued a decision of Substantially Equivalent on August 1, 2003. The device falls under product code NLF (Oximeter, Reprocessed), a Class II device regulated under 21 CFR 870.2700. Hygia Health Services, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2003
Date Received
August 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Reprocessed
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Hygia Health Services, Inc.

  • K100523 — ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENS (May 4, 2010)
  • K090074 — HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS (April 22, 2009)
  • K080424 — HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1 (May 28, 2008)
  • K053575 — HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS (February 15, 2006)
  • K041867 — HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, (September 10, 2004)
  • K032821 — HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF (December 5, 2003)
  • K021509 — HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 (December 24, 2002)
  • K012657 — HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP (April 12, 2002)
  • K012654 — HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DV (April 12, 2002)
  • K012650 — HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP (April 12, 2002)

Other clearances for product code NLF

  • K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul (October 22, 2024)
  • K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls (December 4, 2022)
  • K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 (March 8, 2022)
  • K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (July 22, 2020)
  • K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive (July 3, 2019)
  • K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
  • K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (July 28, 2011)
  • K102560 — REPROCESSED PULSE OXIMETER SENSORS (February 18, 2011)
  • K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (October 7, 2010)
  • K092368 — REPROCESSED PULSE OXIMETER SENSORS (November 3, 2009)

FDA data resources