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FDA 510(k)

Skypro, SP01 Mask

K-Number: K152197 · 2016-08-26

ApplicantSkypro Medical Supplies Company
Decision Date2016-08-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Skypro, SP01 Mask is the device name listed in this FDA 510(k) record. The listed applicant is Skypro Medical Supplies Company. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K152197. 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 Skypro, SP01 Mask?

Skypro, SP01 Mask is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Skypro Medical Supplies Company. The 510(k) number is K152197.

When did Skypro, SP01 Mask receive FDA 510(k) clearance?

Skypro, SP01 Mask received FDA 510(k) clearance on 2016-08-26, under 510(k) number K152197.

Who is the listed applicant for Skypro, SP01 Mask?

The FDA 510(k) record lists Skypro Medical Supplies Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skypro, SP01 Mask?

The FDA product code for Skypro, SP01 Mask is FXX.

Other records listing Skypro Medical Supplies Company 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.

K230707Skypro, Surgical Gown 6021K202255Skypro, SP02 Mask (3)

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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