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FDA 510(k)

WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK

K-Number: K953464 · 1995-09-18

ApplicantWestmed, Inc.
Decision Date1995-09-18
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK is the device name listed in this FDA 510(k) record. The listed applicant is Westmed, Inc.. It received FDA 510(k) clearance on 1995-09-18 under 510(k) number K953464. 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 WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK?

WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Westmed, Inc.. The 510(k) number is K953464.

When did WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK receive FDA 510(k) clearance?

WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK received FDA 510(k) clearance on 1995-09-18, under 510(k) number K953464.

Who is the listed applicant for WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK?

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

What is the FDA product code for WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK?

The FDA product code for WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION 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 Westmed, Inc. 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.

K162343Westmed Gas Sampling Cannula with O2 deliveryK121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]K081905ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPK072220PEDI CO2 EASYK070128CO2 EASY

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 MASKFvtnksK953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.K942907JEMSDAL MASKRespan Products, Inc.

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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