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FDA 510(k)

Percent Oxygen Sensors

K-Number: K213933 · 2022-08-19

ApplicantCareox, LLC
Decision Date2022-08-19
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Percent Oxygen Sensors is a medical device manufactured by Careox, LLC. It received FDA 510(k) clearance on 2022-08-19 under approval 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. It is manufactured by Careox, LLC. The 510(k) number is K213933.

When was Percent Oxygen Sensors approved by the FDA?

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

What company makes Percent Oxygen Sensors?

Percent Oxygen Sensors is manufactured by Careox, LLC.

What is the FDA product code for Percent Oxygen Sensors?

The FDA product code for Percent Oxygen Sensors is CCL.

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Related Devices (Code: CCL)

K153659MaxO2MEMaxtec, LLC K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc. K213948OxyMinderBio-Med Devices, Inc. K221734Maxtec MaxO2 ME+pMaxtec, LLC K251245OxyMinder Pro (10310)Bio-Med Device, Inc. K250002Smart Check O2 (MA0236)Life Spark Medical, LLC

Official Source

View on FDA Database →

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

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