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)

BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR

K-Number: K122702 · 2013-03-18

ApplicantFilligent Limited
Decision Date2013-03-18
Product CodeONT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Filligent Limited. It received FDA 510(k) clearance on 2013-03-18 under 510(k) number K122702. The device is classified under product code ONT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR?

BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR is a medical device that received FDA 510(k) clearance on 2013-03-18. The listed applicant is Filligent Limited. The 510(k) number is K122702.

When did BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR receive FDA 510(k) clearance?

BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR received FDA 510(k) clearance on 2013-03-18, under 510(k) number K122702.

Who is the listed applicant for BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR?

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

What is the FDA product code for BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR?

The FDA product code for BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR is ONT.

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 Filligent Limited 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.

K101128BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

Related Devices (Code: ONT)

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.

K120244SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORNexera Medical, Inc.K090414SPECTRASHIELD 9500 SURGICAL MASKNexera Medical, Inc.K093161ACTIPROTECT UF N95 RESPIRATORGlaxosmithkline Consumer HealthcareK081923ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLDGlaxosmithkline Consumer Healthcare

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.

↑