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FDA 510(k)

WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH

K-Number: K982283 · 1999-03-09

ApplicantCaradyne, Ltd.
Decision Date1999-03-09
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH is the device name listed in this FDA 510(k) record. The listed applicant is Caradyne, Ltd.. It received FDA 510(k) clearance on 1999-03-09 under 510(k) number K982283. 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 WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH?

WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH is a medical device that received FDA 510(k) clearance on 1999-03-09. The listed applicant is Caradyne, Ltd.. The 510(k) number is K982283.

When did WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH receive FDA 510(k) clearance?

WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH received FDA 510(k) clearance on 1999-03-09, under 510(k) number K982283.

Who is the listed applicant for WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH?

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

What is the FDA product code for WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH?

The FDA product code for WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH 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 Caradyne, Ltd. 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.

K040862GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEMK023565OXICHECKK000959CRITERION 60 OR PM 60K992101CRITERION 40 OR PM 40

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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