510(k) K063661

RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 by Renu Medical, Inc. — Product Code NLF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 25, 2007
Date Received: December 8, 2006
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 Renu Medical, Inc.

K203847 — Reprocessed Tri Pulse Compression Garment (May 7, 2021)
K121145 — RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL (June 12, 2012)
K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
K093658 — RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS (January 14, 2010)
K081927 — RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO (February 6, 2009)
K072194 — RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 (November 29, 2007)
K051227 — RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 (April 7, 2006)
K031559 — RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES (November 12, 2003)

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)