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FDA 510(k)

VARIABLE HIGH FLOW DOWNS CPAP GENERATOR

K-Number: K861104 · 1986-04-28

ApplicantMed Air Technology, Inc.
Decision Date1986-04-28
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VARIABLE HIGH FLOW DOWNS CPAP GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Med Air Technology, Inc.. It received FDA 510(k) clearance on 1986-04-28 under 510(k) number K861104. 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 VARIABLE HIGH FLOW DOWNS CPAP GENERATOR?

VARIABLE HIGH FLOW DOWNS CPAP GENERATOR is a medical device that received FDA 510(k) clearance on 1986-04-28. The listed applicant is Med Air Technology, Inc.. The 510(k) number is K861104.

When did VARIABLE HIGH FLOW DOWNS CPAP GENERATOR receive FDA 510(k) clearance?

VARIABLE HIGH FLOW DOWNS CPAP GENERATOR received FDA 510(k) clearance on 1986-04-28, under 510(k) number K861104.

Who is the listed applicant for VARIABLE HIGH FLOW DOWNS CPAP GENERATOR?

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

What is the FDA product code for VARIABLE HIGH FLOW DOWNS CPAP GENERATOR?

The FDA product code for VARIABLE HIGH FLOW DOWNS CPAP GENERATOR 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 Med Air Technology, Inc. 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.

K872202ADJUSTABLE PEEP VALVEK871367HY-FLOW NON-REBREATHING VALVE ASSEMBLY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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