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FDA 510(k)

DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK

K-Number: K945440 · 1994-11-08

ApplicantFvtnks
Decision Date1994-11-08
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Fvtnks. It received FDA 510(k) clearance on 1994-11-08 under 510(k) number K945440. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK?

DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK is a medical device that received FDA 510(k) clearance on 1994-11-08. The listed applicant is Fvtnks. The 510(k) number is K945440.

When did DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK receive FDA 510(k) clearance?

DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK received FDA 510(k) clearance on 1994-11-08, under 510(k) number K945440.

Who is the listed applicant for DISPOSABLE, ANESTHESIA/RESPIRATORY FACE 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, ANESTHESIA/RESPIRATORY FACE MASK?

The FDA product code for DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK is BSJ.

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.

K945482DISPOSABLE, CPAP OXYGEN MASKK940544DOUBLE TRACH SEIVEL CONNECTORK935713WILEY/ESPOSITO DENTAL GUARD

Related Devices (Code: BSJ)

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.

K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.K953107ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing ConceptsK953295ANESTHESIA FACE MASKMallinckrodt MedicalK952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASKOwens-Brigam Medical Co.K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKPromedic, Inc.K950771DISPOSABLE ADHESIVE FACE MASKAdvanced Warming Systems, 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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