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FDA 510(k)

COMPANION 318 NASAL CPAP SYSTEM

K-Number: K903764 · 1990-09-10

ApplicantPuritan Bennett Corp.
Decision Date1990-09-10
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPANION 318 NASAL CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K903764. 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 COMPANION 318 NASAL CPAP SYSTEM?

COMPANION 318 NASAL CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K903764.

When did COMPANION 318 NASAL CPAP SYSTEM receive FDA 510(k) clearance?

COMPANION 318 NASAL CPAP SYSTEM received FDA 510(k) clearance on 1990-09-10, under 510(k) number K903764.

Who is the listed applicant for COMPANION 318 NASAL CPAP SYSTEM?

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

What is the FDA product code for COMPANION 318 NASAL CPAP SYSTEM?

The FDA product code for COMPANION 318 NASAL CPAP SYSTEM is BYE.

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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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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