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FDA 510(k)

CPAP MASK

K-Number: K894690 · 1989-09-08

ApplicantDevilbiss Health Care, Inc.
Decision Date1989-09-08
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPAP MASK 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 1989-09-08 under 510(k) number K894690. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPAP MASK?

CPAP MASK is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Devilbiss Health Care, Inc.. The 510(k) number is K894690.

When did CPAP MASK receive FDA 510(k) clearance?

CPAP MASK received FDA 510(k) clearance on 1989-09-08, under 510(k) number K894690.

Who is the listed applicant for CPAP MASK?

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 CPAP MASK?

The FDA product code for CPAP MASK is BYE.

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: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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