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FDA 510(k)

WESTMED CIRCULARIE PEP DEVICES

K-Number: K955047 · 1996-03-27

ApplicantWestmed Intl.
Decision Date1996-03-27
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WESTMED CIRCULARIE PEP DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Westmed Intl.. It received FDA 510(k) clearance on 1996-03-27 under 510(k) number K955047. 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 WESTMED CIRCULARIE PEP DEVICES?

WESTMED CIRCULARIE PEP DEVICES is a medical device that received FDA 510(k) clearance on 1996-03-27. The listed applicant is Westmed Intl.. The 510(k) number is K955047.

When did WESTMED CIRCULARIE PEP DEVICES receive FDA 510(k) clearance?

WESTMED CIRCULARIE PEP DEVICES received FDA 510(k) clearance on 1996-03-27, under 510(k) number K955047.

Who is the listed applicant for WESTMED CIRCULARIE PEP DEVICES?

The FDA 510(k) record lists Westmed Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WESTMED CIRCULARIE PEP DEVICES?

The FDA product code for WESTMED CIRCULARIE PEP DEVICES is BYE.

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Other records listing Westmed Intl. 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.

K954271WESTMED CONDESATE COLLECTION TRAPK952616MICROTIMEK953687WESTMED PEDIATRIC BACTERIAL/VIRAL FILTERK953506WESTMED RESPIRATORY LUER ADAPTORK951484WESTMED BACTERIAL/VIRAL FILTERK945472WESTMED PEDIATRIC AND ADULT AEROSOL MASK

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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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