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)

EMS PEEP VALVES- ADJUSTABLE

K-Number: K983920 · 1999-01-22

ApplicantEngineered Medical Systems
Decision Date1999-01-22
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMS PEEP VALVES- ADJUSTABLE 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 1999-01-22 under 510(k) number K983920. 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 EMS PEEP VALVES- ADJUSTABLE?

EMS PEEP VALVES- ADJUSTABLE is a medical device that received FDA 510(k) clearance on 1999-01-22. The listed applicant is Engineered Medical Systems. The 510(k) number is K983920.

When did EMS PEEP VALVES- ADJUSTABLE receive FDA 510(k) clearance?

EMS PEEP VALVES- ADJUSTABLE received FDA 510(k) clearance on 1999-01-22, under 510(k) number K983920.

Who is the listed applicant for EMS PEEP VALVES- ADJUSTABLE?

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 EMS PEEP VALVES- ADJUSTABLE?

The FDA product code for EMS PEEP VALVES- ADJUSTABLE 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 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 COMBINATIONK013123EMS PULMONARY FUNCTION TESTING FILTERK013089EMS HEPA FILTER AND HME COMBINATIONSK003497DISPOSABLE PRESSURE MONITOR

View all 22 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.

↑