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FDA 510(k)

OXYGEN SENSING DEVICE, MODIFICATION

K-Number: K913392 · 1992-07-17

ApplicantDevilbiss Health Care, Inc.
Decision Date1992-07-17
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN SENSING DEVICE, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Health Care, Inc.. It received FDA 510(k) clearance on 1992-07-17 under 510(k) number K913392. 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 OXYGEN SENSING DEVICE, MODIFICATION?

OXYGEN SENSING DEVICE, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-07-17. The listed applicant is Devilbiss Health Care, Inc.. The 510(k) number is K913392.

When did OXYGEN SENSING DEVICE, MODIFICATION receive FDA 510(k) clearance?

OXYGEN SENSING DEVICE, MODIFICATION received FDA 510(k) clearance on 1992-07-17, under 510(k) number K913392.

Who is the listed applicant for OXYGEN SENSING DEVICE, MODIFICATION?

The FDA 510(k) record lists Devilbiss Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYGEN SENSING DEVICE, MODIFICATION?

The FDA product code for OXYGEN SENSING DEVICE, MODIFICATION is CCL.

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Other records listing Devilbiss Health Care, 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.

K963349DEVILBISS 8650DK970289COMPRESSOR/NEBULIZER #3650K961126PULSE DOSE SERIESK950849MODEL #7354K952491MODEL 7355K952249JET NEBULIZER

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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 LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

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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