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FDA 510(k)

WATERPAP VALVE

K-Number: K110713 · 2011-09-12

ApplicantAirways Development, LLC
Decision Date2011-09-12
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WATERPAP VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Airways Development, LLC. It received FDA 510(k) clearance on 2011-09-12 under 510(k) number K110713. 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 WATERPAP VALVE?

WATERPAP VALVE is a medical device that received FDA 510(k) clearance on 2011-09-12. The listed applicant is Airways Development, LLC. The 510(k) number is K110713.

When did WATERPAP VALVE receive FDA 510(k) clearance?

WATERPAP VALVE received FDA 510(k) clearance on 2011-09-12, under 510(k) number K110713.

Who is the listed applicant for WATERPAP VALVE?

The FDA 510(k) record lists Airways Development, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WATERPAP VALVE?

The FDA product code for WATERPAP VALVE is BYE.

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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.K103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KGK090710MERCURY CPAPMercury Medical

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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