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)

DISPOSABLE, PREFORMED FACE MASK

K-Number: K944157 · 1994-10-03

ApplicantMeridian Medical Systems, Inc.
Decision Date1994-10-03
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE, PREFORMED FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K944157. 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, PREFORMED FACE MASK?

DISPOSABLE, PREFORMED FACE MASK is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Meridian Medical Systems, Inc.. The 510(k) number is K944157.

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

DISPOSABLE, PREFORMED FACE MASK received FDA 510(k) clearance on 1994-10-03, under 510(k) number K944157.

Who is the listed applicant for DISPOSABLE, PREFORMED FACE MASK?

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

What is the FDA product code for DISPOSABLE, PREFORMED FACE MASK?

The FDA product code for DISPOSABLE, PREFORMED 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 Meridian Medical 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.

K945984MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS

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.

↑