FDA 510(k)

OxyMinder

K-Number: K213948 · 2022-03-17

Decision Date2022-03-17

Product CodeCCL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

OxyMinder is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Devices, Inc.. It received FDA 510(k) clearance on 2022-03-17 under 510(k) 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. The listed applicant is Bio-Med Devices, Inc.. The 510(k) number is K213948.

When did OxyMinder receive FDA 510(k) clearance?

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

Who is the listed applicant for OxyMinder?

The FDA 510(k) record lists Bio-Med Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OxyMinder?

The FDA product code for OxyMinder is CCL.

Other records listing Bio-Med Devices, Inc. as applicant

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.

K173973TV-100

Related Devices (Code: CCL)

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 K213933Percent Oxygen SensorsCareox, LLC 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.