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FDA 510(k)

PEEP/CPAP VALVE

K-Number: K781332 · 1978-10-04

ApplicantVickers America Medical Corp.
Decision Date1978-10-04
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEEP/CPAP VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Vickers America Medical Corp.. It received FDA 510(k) clearance on 1978-10-04 under 510(k) number K781332. 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 PEEP/CPAP VALVE?

PEEP/CPAP VALVE is a medical device that received FDA 510(k) clearance on 1978-10-04. The listed applicant is Vickers America Medical Corp.. The 510(k) number is K781332.

When did PEEP/CPAP VALVE receive FDA 510(k) clearance?

PEEP/CPAP VALVE received FDA 510(k) clearance on 1978-10-04, under 510(k) number K781332.

Who is the listed applicant for PEEP/CPAP VALVE?

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

What is the FDA product code for PEEP/CPAP VALVE?

The FDA product code for PEEP/CPAP VALVE is BYE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vickers America Medical Corp. 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.

K840823TREONIC C30K831838LABORATORY DATA MGMT SYSTEM SDMSK830748RESUSCITAIREK830936TREONIC IP5K813239OXYGENAIRE NURING INCUBATORK813238NEOCARE BABY-CONTROLLED INCUBATOR

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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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