Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WESTMED PEDIATRIC AND ADULT AEROSOL MASK

K-Number: K945472 · 1995-02-07

ApplicantWestmed Intl.
Decision Date1995-02-07
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WESTMED PEDIATRIC AND ADULT AEROSOL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Westmed Intl.. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K945472. 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 AND ADULT AEROSOL MASK?

WESTMED PEDIATRIC AND ADULT AEROSOL MASK is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Westmed Intl.. The 510(k) number is K945472.

When did WESTMED PEDIATRIC AND ADULT AEROSOL MASK receive FDA 510(k) clearance?

WESTMED PEDIATRIC AND ADULT AEROSOL MASK received FDA 510(k) clearance on 1995-02-07, under 510(k) number K945472.

Who is the listed applicant for WESTMED PEDIATRIC AND ADULT AEROSOL MASK?

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

What is the FDA product code for WESTMED PEDIATRIC AND ADULT AEROSOL MASK?

The FDA product code for WESTMED PEDIATRIC AND ADULT AEROSOL 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 Intl. 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.

K955047WESTMED CIRCULARIE PEP DEVICESK954271WESTMED CONDESATE COLLECTION TRAPK952616MICROTIMEK953687WESTMED PEDIATRIC BACTERIAL/VIRAL FILTERK953506WESTMED RESPIRATORY LUER ADAPTORK951484WESTMED BACTERIAL/VIRAL FILTER

View all 9 devices →

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.K942907JEMSDAL MASKRespan Products, 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.

↑