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)

MASKA, OXYGEN VINYL D-SP. SINGLE USE

K-Number: K760219 · 1976-08-03

ApplicantManner Medical Products
Decision Date1976-08-03
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASKA, OXYGEN VINYL D-SP. SINGLE USE is the device name listed in this FDA 510(k) record. The listed applicant is Manner Medical Products. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760219. 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 MASKA, OXYGEN VINYL D-SP. SINGLE USE?

MASKA, OXYGEN VINYL D-SP. SINGLE USE is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Manner Medical Products. The 510(k) number is K760219.

When did MASKA, OXYGEN VINYL D-SP. SINGLE USE receive FDA 510(k) clearance?

MASKA, OXYGEN VINYL D-SP. SINGLE USE received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760219.

Who is the listed applicant for MASKA, OXYGEN VINYL D-SP. SINGLE USE?

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

What is the FDA product code for MASKA, OXYGEN VINYL D-SP. SINGLE USE?

The FDA product code for MASKA, OXYGEN VINYL D-SP. SINGLE USE 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 Manner Medical Products 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.

K760220TUBING, SINGLE USE OXYGEN SUPPLYK760218CANNULAE, PLASTIC DISPOSABLE NASALK760221I.P.P.B., DIS. W/MANIFOLD/NEBULIZER

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.

↑