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FDA 510(k)

OXYGEN MASKS

K-Number: K823141 · 1982-11-29

ApplicantSeven Harvest Intl. Import & Export
Decision Date1982-11-29
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Seven Harvest Intl. Import & Export. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823141. 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 OXYGEN MASKS?

OXYGEN MASKS is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Seven Harvest Intl. Import & Export. The 510(k) number is K823141.

When did OXYGEN MASKS receive FDA 510(k) clearance?

OXYGEN MASKS received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823141.

Who is the listed applicant for OXYGEN MASKS?

The FDA 510(k) record lists Seven Harvest Intl. Import & Export as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYGEN MASKS?

The FDA product code for OXYGEN MASKS 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 Seven Harvest Intl. Import & Export 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.

K940793DOUBLE TRACH SWIVEL CONNECTORK823506NASAL CANNULAK823143BUBBLE HUMIDIFIERSK823142OXYGEN TUBINGSK820709AIRWAYSK813074CONNECTORS & ADAPTERS

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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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