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FDA 510(k)

WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)

K-Number: K001997 · 2001-04-02

ApplicantWhite Knight Healthcare, Inc.
Decision Date2001-04-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) is the device name listed in this FDA 510(k) record. The listed applicant is White Knight Healthcare, Inc.. It received FDA 510(k) clearance on 2001-04-02 under 510(k) number K001997. 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 WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)?

WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) is a medical device that received FDA 510(k) clearance on 2001-04-02. The listed applicant is White Knight Healthcare, Inc.. The 510(k) number is K001997.

When did WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) receive FDA 510(k) clearance?

WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) received FDA 510(k) clearance on 2001-04-02, under 510(k) number K001997.

Who is the listed applicant for WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)?

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

What is the FDA product code for WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)?

The FDA product code for WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) 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.

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Other records listing White Knight Healthcare, 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.

K001892WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)K001893WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)

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

View on FDA Database →

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

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