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FDA 510(k)

OXY-DIAL

K-Number: K852618 · 1985-09-18

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

Device Summary

OXY-DIAL 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 K852618. The device is classified under product code BYF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXY-DIAL?

OXY-DIAL 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 K852618.

When did OXY-DIAL receive FDA 510(k) clearance?

OXY-DIAL received FDA 510(k) clearance on 1985-09-18, under 510(k) number K852618.

Who is the listed applicant for OXY-DIAL?

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 OXY-DIAL?

The FDA product code for OXY-DIAL is BYF.

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-NEBK852629AERO-MASK TWOK852625OXY-TUBE

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Related Devices (Code: BYF)

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.

K955483TRACH MASK MODEL (245, 246)Hospitak, Inc.K951652VENTIMASK MK IVFlexicare Medical, Ltd.K894457CARNATION TRACHEOSTOMY MASKSDadsun Corp., Ltd.K860873VENTURI MASK/ADULT & PAEDIATRICDhd Medical Products Div. Diemolding Corp.K860874VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRICDhd Medical Products Div. Diemolding Corp.K832725DUAL DIAL VENTURI STYLE MASKAirlife, Inc.

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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