510(k) K012600

CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L by Clearmedical, Inc. — Product Code NLF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 3, 2002
Date Received: August 13, 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 Clearmedical, Inc.

K033579 — REPROCESSED MULTIPLE CLIP APPLIERS (July 11, 2005)
K033578 — REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (July 11, 2005)
K033591 — REPROCESSED TROCARS (June 3, 2005)
K033592 — REPROCESSED SURGICAL SCISSORS AND GRASPERS (July 27, 2004)
K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (November 20, 2003)
K031416 — CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSU (July 15, 2003)
K012622 — CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 (July 3, 2002)
K012609 — CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 (July 3, 2002)
K012612 — CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE (February 6, 2002)
K012616 — CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STAND (February 6, 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)