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FDA 510(k)

DISPOSABLE ADHESIVE FACE MASK

K-Number: K950771 · 1995-03-10

ApplicantAdvanced Warming Systems, Inc.
Decision Date1995-03-10
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ADHESIVE FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Warming Systems, Inc.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K950771. 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 ADHESIVE FACE MASK?

DISPOSABLE ADHESIVE FACE MASK is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Advanced Warming Systems, Inc.. The 510(k) number is K950771.

When did DISPOSABLE ADHESIVE FACE MASK receive FDA 510(k) clearance?

DISPOSABLE ADHESIVE FACE MASK received FDA 510(k) clearance on 1995-03-10, under 510(k) number K950771.

Who is the listed applicant for DISPOSABLE ADHESIVE FACE MASK?

The FDA 510(k) record lists Advanced Warming Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE ADHESIVE FACE MASK?

The FDA product code for DISPOSABLE ADHESIVE 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 Advanced Warming Systems, Inc. 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.

K953269SAFECIRCUIT MANIFOLD/PULMONARY UNITK913016WARMTOUCH

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.K945894MASK, GAS, ANESTHETICHans Rudolph, 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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