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510(k) K201699

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor by Surgical Instrument and Savings Inc (Dba Medline Renewal) — Product Code NLF

K201699 is an FDA 510(k) premarket notification submitted by Surgical Instrument and Savings Inc (Dba Medline Renewal) for the device "Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor". The FDA issued a decision of Substantially Equivalent on July 22, 2020. The device falls under product code NLF (Oximeter, Reprocessed), a Class II device regulated under 21 CFR 870.2700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2020
Date Received
June 22, 2020
Clearance Type
Special
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 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)
  • 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)
  • K083719 — LNCS OXIMETRY SENSORS (July 30, 2009)

FDA data resources