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FDA 510(k)

VENTIMASK MK IV

K-Number: K951652 · 1995-04-27

ApplicantFlexicare Medical, Ltd.
Decision Date1995-04-27
Product CodeBYF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTIMASK MK IV is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical, Ltd.. It received FDA 510(k) clearance on 1995-04-27 under 510(k) number K951652. The device is classified under product code BYF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTIMASK MK IV?

VENTIMASK MK IV is a medical device that received FDA 510(k) clearance on 1995-04-27. The listed applicant is Flexicare Medical, Ltd.. The 510(k) number is K951652.

When did VENTIMASK MK IV receive FDA 510(k) clearance?

VENTIMASK MK IV received FDA 510(k) clearance on 1995-04-27, under 510(k) number K951652.

Who is the listed applicant for VENTIMASK MK IV?

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

What is the FDA product code for VENTIMASK MK IV?

The FDA product code for VENTIMASK MK IV is BYF.

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 Flexicare Medical, 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.

K132619CLASSIC INTERMITTENT CATHETERK092218FLEXICARE BREATHING FILTERSK091591FLEXICARE MEDICAL ENDOTRACHEAL TUBES

Related Devices (Code: BYF)

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.

K955483TRACH MASK MODEL (245, 246)Hospitak, Inc.K894457CARNATION TRACHEOSTOMY MASKSDadsun Corp., Ltd.K860873VENTURI MASK/ADULT & PAEDIATRICDhd Medical Products Div. Diemolding Corp.K860874VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRICDhd Medical Products Div. Diemolding Corp.K852618OXY-DIALAshai Co. , Ltd.K832725DUAL DIAL VENTURI STYLE MASKAirlife, 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.

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