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FDA 510(k)

DISPOSABLE, CPAP OXYGEN MASK

K-Number: K945482 · 1995-09-19

ApplicantFvtnks
Decision Date1995-09-19
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE, CPAP OXYGEN MASK is the device name listed in this FDA 510(k) record. The listed applicant is Fvtnks. It received FDA 510(k) clearance on 1995-09-19 under 510(k) number K945482. 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 DISPOSABLE, CPAP OXYGEN MASK?

DISPOSABLE, CPAP OXYGEN MASK is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Fvtnks. The 510(k) number is K945482.

When did DISPOSABLE, CPAP OXYGEN MASK receive FDA 510(k) clearance?

DISPOSABLE, CPAP OXYGEN MASK received FDA 510(k) clearance on 1995-09-19, under 510(k) number K945482.

Who is the listed applicant for DISPOSABLE, CPAP OXYGEN MASK?

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

What is the FDA product code for DISPOSABLE, CPAP OXYGEN MASK?

The FDA product code for DISPOSABLE, CPAP 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 Fvtnks 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.

K945440DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASKK940544DOUBLE TRACH SEIVEL CONNECTORK935713WILEY/ESPOSITO DENTAL GUARD

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.K953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS 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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