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FDA 510(k)

OxyMinder

K-Number: K213948 · 2022-03-17

ApplicantBio-Med Devices, Inc.
Decision Date2022-03-17
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OxyMinder is a medical device manufactured by Bio-Med Devices, Inc.. It received FDA 510(k) clearance on 2022-03-17 under approval number K213948. 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 OxyMinder?

OxyMinder is a medical device that received FDA 510(k) clearance on 2022-03-17. It is manufactured by Bio-Med Devices, Inc.. The 510(k) number is K213948.

When was OxyMinder approved by the FDA?

OxyMinder received FDA 510(k) clearance on 2022-03-17, under approval number K213948.

What company makes OxyMinder?

OxyMinder is manufactured by Bio-Med Devices, Inc..

What is the FDA product code for OxyMinder?

The FDA product code for OxyMinder is CCL.

Other Devices by Bio-Med Devices, Inc.

K173973TV-100

Related Devices (Code: CCL)

K153659MaxO2MEMaxtec, LLC K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc. K213933Percent Oxygen SensorsCareox, LLC 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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