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FDA 510(k)

DELTA N95 RESPIRATOR

K-Number: K964722 · 1997-02-07

ApplicantRacal Filter Technologies, Inc.
Decision Date1997-02-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DELTA N95 RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Racal Filter Technologies, Inc.. It received FDA 510(k) clearance on 1997-02-07 under 510(k) number K964722. 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 DELTA N95 RESPIRATOR?

DELTA N95 RESPIRATOR is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is Racal Filter Technologies, Inc.. The 510(k) number is K964722.

When did DELTA N95 RESPIRATOR receive FDA 510(k) clearance?

DELTA N95 RESPIRATOR received FDA 510(k) clearance on 1997-02-07, under 510(k) number K964722.

Who is the listed applicant for DELTA N95 RESPIRATOR?

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

What is the FDA product code for DELTA N95 RESPIRATOR?

The FDA product code for DELTA N95 RESPIRATOR 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 Racal Filter Technologies, 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.

K964723RACAL N95 RESIRATOR

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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