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FDA 510(k)

REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142

K-Number: K963347 · 1997-03-19

ApplicantInstrumentation Industries, Inc.
Decision Date1997-03-19
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Industries, Inc.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K963347. 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 REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142?

REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K963347.

When did REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 receive FDA 510(k) clearance?

REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 received FDA 510(k) clearance on 1997-03-19, under 510(k) number K963347.

Who is the listed applicant for REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142?

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

What is the FDA product code for REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142?

The FDA product code for REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 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.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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