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)

PEDIATRIC OXYGEN MASKS

K-Number: K811711 · 1981-07-01

ApplicantAirlife, Inc.
Decision Date1981-07-01
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC OXYGEN MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811711. 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 PEDIATRIC OXYGEN MASKS?

PEDIATRIC OXYGEN MASKS is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Airlife, Inc.. The 510(k) number is K811711.

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

PEDIATRIC OXYGEN MASKS received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811711.

Who is the listed applicant for PEDIATRIC OXYGEN MASKS?

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

What is the FDA product code for PEDIATRIC OXYGEN MASKS?

The FDA product code for PEDIATRIC 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.

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 Airlife, 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.

K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASK

View all 76 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.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.

↑