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FDA 510(k)

PEGASUS NASAL CPAP SYSTEM

K-Number: K022192 · 2003-01-24

ApplicantSensor Medics Corp.
Decision Date2003-01-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEGASUS NASAL CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sensor Medics Corp.. It received FDA 510(k) clearance on 2003-01-24 under 510(k) number K022192. 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 PEGASUS NASAL CPAP SYSTEM?

PEGASUS NASAL CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Sensor Medics Corp.. The 510(k) number is K022192.

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

PEGASUS NASAL CPAP SYSTEM received FDA 510(k) clearance on 2003-01-24, under 510(k) number K022192.

Who is the listed applicant for PEGASUS NASAL CPAP SYSTEM?

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

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

The FDA product code for PEGASUS NASAL CPAP SYSTEM is BZD.

Related Clinical Trials

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Other records listing Sensor Medics 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.

K032516HIOX80 AEROSOL ADAPTERK031745INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONK031883LYRA NASAL MASKK030943MODIFICATION TO HIOXK020665HI-OXK012085SOMNO STAR & SERIES SLEEP SYSTEM

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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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