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FDA 510(k)

SULLIVAN NASAL CPAP SYSTEM

K-Number: K882292 · 1988-06-21

ApplicantBaxter Centre For Medical Research
Decision Date1988-06-21
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SULLIVAN NASAL CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Centre For Medical Research. It received FDA 510(k) clearance on 1988-06-21 under 510(k) number K882292. 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 SULLIVAN NASAL CPAP SYSTEM?

SULLIVAN NASAL CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 1988-06-21. The listed applicant is Baxter Centre For Medical Research. The 510(k) number is K882292.

When did SULLIVAN NASAL CPAP SYSTEM receive FDA 510(k) clearance?

SULLIVAN NASAL CPAP SYSTEM received FDA 510(k) clearance on 1988-06-21, under 510(k) number K882292.

Who is the listed applicant for SULLIVAN NASAL CPAP SYSTEM?

The FDA 510(k) record lists Baxter Centre For Medical Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SULLIVAN NASAL CPAP SYSTEM?

The FDA product code for SULLIVAN NASAL CPAP SYSTEM 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

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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