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FDA 510(k)

SLEEPAP

K-Number: K905593 · 1991-04-23

ApplicantMedical Industries America, Inc.
Decision Date1991-04-23
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPAP is the device name listed in this FDA 510(k) record. The listed applicant is Medical Industries America, Inc.. It received FDA 510(k) clearance on 1991-04-23 under 510(k) number K905593. 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 SLEEPAP?

SLEEPAP is a medical device that received FDA 510(k) clearance on 1991-04-23. The listed applicant is Medical Industries America, Inc.. The 510(k) number is K905593.

When did SLEEPAP receive FDA 510(k) clearance?

SLEEPAP received FDA 510(k) clearance on 1991-04-23, under 510(k) number K905593.

Who is the listed applicant for SLEEPAP?

The FDA 510(k) record lists Medical Industries America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLEEPAP?

The FDA product code for SLEEPAP is BZD.

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Other records listing Medical Industries America, Inc. 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.

K050990REMREST HEATED HUMIDIFIERK032170TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000K002763REMRESTK011053OPTIMAK9640783050 SPORT-NEBK9439903000 AEROSOL TWO

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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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