Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)

K-Number: K881614 · 1988-04-29

ApplicantOhmeda Medical
Decision Date1988-04-29
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1988-04-29 under 510(k) number K881614. 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 MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)?

MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) is a medical device that received FDA 510(k) clearance on 1988-04-29. The listed applicant is Ohmeda Medical. The 510(k) number is K881614.

When did MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) receive FDA 510(k) clearance?

MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) received FDA 510(k) clearance on 1988-04-29, under 510(k) number K881614.

Who is the listed applicant for MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)?

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

What is the FDA product code for MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)?

The FDA product code for MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) 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 Ohmeda Medical 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.

K123309GIRAFFE AND PANDA WARMERSK101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA WARMER

View all 119 devices →

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.

↑