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)

VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS

K-Number: K953039 · 1995-09-15

ApplicantDadsun Corp., Ltd.
Decision Date1995-09-15
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Dadsun Corp., Ltd.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K953039. 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 VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS?

VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Dadsun Corp., Ltd.. The 510(k) number is K953039.

When did VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS receive FDA 510(k) clearance?

VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953039.

Who is the listed applicant for VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS?

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

What is the FDA product code for VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS?

The FDA product code for VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY 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 Dadsun Corp., Ltd. 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.

K894457CARNATION TRACHEOSTOMY MASKSK851466CARNATION - OXYGEN MASK

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.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.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.

↑