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FDA 510(k)

AERO-MASK ONE

K-Number: K852626 · 1985-09-18

ApplicantAshai Co. , Ltd.
Decision Date1985-09-18
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AERO-MASK ONE is the device name listed in this FDA 510(k) record. The listed applicant is Ashai Co. , Ltd.. It received FDA 510(k) clearance on 1985-09-18 under 510(k) number K852626. 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 AERO-MASK ONE?

AERO-MASK ONE is a medical device that received FDA 510(k) clearance on 1985-09-18. The listed applicant is Ashai Co. , Ltd.. The 510(k) number is K852626.

When did AERO-MASK ONE receive FDA 510(k) clearance?

AERO-MASK ONE received FDA 510(k) clearance on 1985-09-18, under 510(k) number K852626.

Who is the listed applicant for AERO-MASK ONE?

The FDA 510(k) record lists Ashai Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AERO-MASK ONE?

The FDA product code for AERO-MASK ONE is BYG.

Other records listing Ashai Co. , Ltd. 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.

K870428AEROSOL ONE, NEBULIZER PUMPK852622AEROSOL ONEK852620SAFE.N.SUREK852627MAXI-NEBK852625OXY-TUBEK852618OXY-DIAL

View all 12 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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