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FDA 510(k)

N95 FILTERING FACEPIECE

K-Number: K962443 · 1997-01-03

ApplicantSurvivair, Inc.
Decision Date1997-01-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

N95 FILTERING FACEPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Survivair, Inc.. It received FDA 510(k) clearance on 1997-01-03 under 510(k) number K962443. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N95 FILTERING FACEPIECE?

N95 FILTERING FACEPIECE is a medical device that received FDA 510(k) clearance on 1997-01-03. The listed applicant is Survivair, Inc.. The 510(k) number is K962443.

When did N95 FILTERING FACEPIECE receive FDA 510(k) clearance?

N95 FILTERING FACEPIECE received FDA 510(k) clearance on 1997-01-03, under 510(k) number K962443.

Who is the listed applicant for N95 FILTERING FACEPIECE?

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

What is the FDA product code for N95 FILTERING FACEPIECE?

The FDA product code for N95 FILTERING FACEPIECE is FXX.

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 Survivair, 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.

K070139WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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