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FDA 510(k)

DEVILBISS MODEL 5500

K-Number: K946095 · 1995-08-24

ApplicantDevilbiss Health Care, Inc.
Decision Date1995-08-24
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS MODEL 5500 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 1995-08-24 under 510(k) number K946095. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVILBISS MODEL 5500?

DEVILBISS MODEL 5500 is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Devilbiss Health Care, Inc.. The 510(k) number is K946095.

When did DEVILBISS MODEL 5500 receive FDA 510(k) clearance?

DEVILBISS MODEL 5500 received FDA 510(k) clearance on 1995-08-24, under 510(k) number K946095.

Who is the listed applicant for DEVILBISS MODEL 5500?

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 DEVILBISS MODEL 5500?

The FDA product code for DEVILBISS MODEL 5500 is CAF.

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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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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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