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FDA 510(k)

SINGLE USE MANUAL RESUSCITATOR PEEP VALVE

K-Number: K932799 · 1993-09-03

ApplicantEngineered Medical Systems
Decision Date1993-09-03
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SINGLE USE MANUAL RESUSCITATOR PEEP VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 1993-09-03 under 510(k) number K932799. 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 SINGLE USE MANUAL RESUSCITATOR PEEP VALVE?

SINGLE USE MANUAL RESUSCITATOR PEEP VALVE is a medical device that received FDA 510(k) clearance on 1993-09-03. The listed applicant is Engineered Medical Systems. The 510(k) number is K932799.

When did SINGLE USE MANUAL RESUSCITATOR PEEP VALVE receive FDA 510(k) clearance?

SINGLE USE MANUAL RESUSCITATOR PEEP VALVE received FDA 510(k) clearance on 1993-09-03, under 510(k) number K932799.

Who is the listed applicant for SINGLE USE MANUAL RESUSCITATOR PEEP VALVE?

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

What is the FDA product code for SINGLE USE MANUAL RESUSCITATOR PEEP VALVE?

The FDA product code for SINGLE USE MANUAL RESUSCITATOR PEEP VALVE is BYE.

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Other records listing Engineered Medical Systems 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.

K023683MULTI-STRAP FULL FACE MASKK013728TRACH VOXK013122EMS ELECTROSTATIC FLITER AND HME COMBINATIONK013089EMS HEPA FILTER AND HME COMBINATIONSK013123EMS PULMONARY FUNCTION TESTING FILTERK003497DISPOSABLE PRESSURE MONITOR

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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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