FDA 510(k)

Percent Oxygen Sensors

K-Number: K213933 · 2022-08-19

Decision Date2022-08-19

Product CodeCCL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Percent Oxygen Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Careox, LLC. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K213933. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Percent Oxygen Sensors?

Percent Oxygen Sensors is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Careox, LLC. The 510(k) number is K213933.

When did Percent Oxygen Sensors receive FDA 510(k) clearance?

Percent Oxygen Sensors received FDA 510(k) clearance on 2022-08-19, under 510(k) number K213933.

Who is the listed applicant for Percent Oxygen Sensors?

The FDA 510(k) record lists Careox, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Percent Oxygen Sensors?

The FDA product code for Percent Oxygen Sensors is CCL.

Related Devices (Code: CCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs K251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLC K221734Maxtec MaxO2 ME+pMaxtec, LLC K213948OxyMinderBio-Med Devices, Inc.K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.