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FDA 510(k)

CARNATION - OXYGEN MASK

K-Number: K851466 · 1985-06-19

ApplicantDadsun Corp., Ltd.
Decision Date1985-06-19
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARNATION - OXYGEN MASK is the device name listed in this FDA 510(k) record. The listed applicant is Dadsun Corp., Ltd.. It received FDA 510(k) clearance on 1985-06-19 under 510(k) number K851466. 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 CARNATION - OXYGEN MASK?

CARNATION - OXYGEN MASK is a medical device that received FDA 510(k) clearance on 1985-06-19. The listed applicant is Dadsun Corp., Ltd.. The 510(k) number is K851466.

When did CARNATION - OXYGEN MASK receive FDA 510(k) clearance?

CARNATION - OXYGEN MASK received FDA 510(k) clearance on 1985-06-19, under 510(k) number K851466.

Who is the listed applicant for CARNATION - OXYGEN MASK?

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

What is the FDA product code for CARNATION - OXYGEN MASK?

The FDA product code for CARNATION - OXYGEN 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 Dadsun Corp., 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.

K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSK894457CARNATION TRACHEOSTOMY MASKS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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