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FDA 510(k)

SLEEPAP MASK

K-Number: K894642 · 1989-10-19

ApplicantMedical Industries America, Inc.
Decision Date1989-10-19
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPAP MASK 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 1989-10-19 under 510(k) number K894642. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPAP MASK?

SLEEPAP MASK is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Medical Industries America, Inc.. The 510(k) number is K894642.

When did SLEEPAP MASK receive FDA 510(k) clearance?

SLEEPAP MASK received FDA 510(k) clearance on 1989-10-19, under 510(k) number K894642.

Who is the listed applicant for SLEEPAP MASK?

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 MASK?

The FDA product code for SLEEPAP MASK is BYG.

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 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

View all 19 devices →

Related Devices (Code: BYG)

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.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

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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