510(k) K042891

DATEX-OHMEDA OXY-AFR SENSOR by Datex-Ohmeda — Product Code NLF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 29, 2005
Date Received: October 19, 2004
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 Datex-Ohmeda

K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
K213867 — Carestation 750/750c (March 28, 2023)
K210384 — CARESCAPE R860 (November 4, 2021)
K172702 — Tec 820, Tec 850 (January 4, 2018)
K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
K170872 — Aisys CS2 (August 15, 2017)
K151570 — Carestation 620/650/650C (January 21, 2016)
K142679 — CARESCAPE R860 (June 12, 2015)
K143530 — Aespire View (April 24, 2015)
K140575 — ENGSTROM CARESTATION, ENGSTROM PRO (February 3, 2015)

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)