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FDA 510(k)

BODY FLUIDS BARRIER KIT

K-Number: K944545 · 1994-11-02

ApplicantAni Safety, Inc.
Decision Date1994-11-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BODY FLUIDS BARRIER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ani Safety, Inc.. It received FDA 510(k) clearance on 1994-11-02 under 510(k) number K944545. 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 BODY FLUIDS BARRIER KIT?

BODY FLUIDS BARRIER KIT is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Ani Safety, Inc.. The 510(k) number is K944545.

When did BODY FLUIDS BARRIER KIT receive FDA 510(k) clearance?

BODY FLUIDS BARRIER KIT received FDA 510(k) clearance on 1994-11-02, under 510(k) number K944545.

Who is the listed applicant for BODY FLUIDS BARRIER KIT?

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

What is the FDA product code for BODY FLUIDS BARRIER KIT?

The FDA product code for BODY FLUIDS BARRIER KIT 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 Ani Safety, 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.

K946001EMERGENCY RESPONSE SAFETY KIT

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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