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FDA 510(k)

MEDWAY OXYGEN MASK

K-Number: K931952 · 1993-08-20

ApplicantMedway
Decision Date1993-08-20
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDWAY OXYGEN MASK is the device name listed in this FDA 510(k) record. The listed applicant is Medway. It received FDA 510(k) clearance on 1993-08-20 under 510(k) number K931952. 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 MEDWAY OXYGEN MASK?

MEDWAY OXYGEN MASK is a medical device that received FDA 510(k) clearance on 1993-08-20. The listed applicant is Medway. The 510(k) number is K931952.

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

MEDWAY OXYGEN MASK received FDA 510(k) clearance on 1993-08-20, under 510(k) number K931952.

Who is the listed applicant for MEDWAY OXYGEN MASK?

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

What is the FDA product code for MEDWAY OXYGEN MASK?

The FDA product code for MEDWAY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medway 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.

K934344HOME AMB-ALERTK911251FLEX-IVK911079AMB-ALERTK910880COMFOR-BOARD

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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