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FDA 510(k)

CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM

K-Number: K935979 · 1994-11-10

ApplicantDevilbiss Health Care, Inc.
Decision Date1994-11-10
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Health Care, Inc.. It received FDA 510(k) clearance on 1994-11-10 under 510(k) number K935979. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM?

CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Devilbiss Health Care, Inc.. The 510(k) number is K935979.

When did CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM receive FDA 510(k) clearance?

CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM received FDA 510(k) clearance on 1994-11-10, under 510(k) number K935979.

Who is the listed applicant for CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM?

The FDA 510(k) record lists Devilbiss Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM?

The FDA product code for CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM is BZD.

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 Devilbiss Health Care, 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.

K963349DEVILBISS 8650DK970289COMPRESSOR/NEBULIZER #3650K961126PULSE DOSE SERIESK950849MODEL #7354K952491MODEL 7355K952249JET NEBULIZER

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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