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FDA 510(k)

MEDTRONIC SULLIVAN NASAL CPAP SYSTEM

K-Number: K905404 · 1991-05-13

ApplicantMedtronic Vascular
Decision Date1991-05-13
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC SULLIVAN NASAL CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K905404. 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 MEDTRONIC SULLIVAN NASAL CPAP SYSTEM?

MEDTRONIC SULLIVAN NASAL CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Medtronic Vascular. The 510(k) number is K905404.

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

MEDTRONIC SULLIVAN NASAL CPAP SYSTEM received FDA 510(k) clearance on 1991-05-13, under 510(k) number K905404.

Who is the listed applicant for MEDTRONIC SULLIVAN NASAL CPAP SYSTEM?

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

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

The FDA product code for MEDTRONIC SULLIVAN NASAL 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.

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Other records listing Medtronic Vascular as applicant

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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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