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FDA 510(k)

PURITAN-BENNETT NASAL CPAP MASK

K-Number: K942246 · 1994-07-06

ApplicantPuritan-Bennett
Decision Date1994-07-06
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PURITAN-BENNETT NASAL CPAP MASK is the device name listed in this FDA 510(k) record. The listed applicant is Puritan-Bennett. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K942246. 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 PURITAN-BENNETT NASAL CPAP MASK?

PURITAN-BENNETT NASAL CPAP MASK is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Puritan-Bennett. The 510(k) number is K942246.

When did PURITAN-BENNETT NASAL CPAP MASK receive FDA 510(k) clearance?

PURITAN-BENNETT NASAL CPAP MASK received FDA 510(k) clearance on 1994-07-06, under 510(k) number K942246.

Who is the listed applicant for PURITAN-BENNETT NASAL CPAP MASK?

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

What is the FDA product code for PURITAN-BENNETT NASAL CPAP MASK?

The FDA product code for PURITAN-BENNETT NASAL CPAP MASK 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 Puritan-Bennett 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.

K021573PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTIONK943617DISPOSABLE MANUAL RESUSCITATORK935784PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM

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.

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