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FDA 510(k)

Communicator Surgical Facemask with Clear Window

K-Number: K152561 · 2016-06-03

ApplicantPrestige Ameritech , Ltd.
Decision Date2016-06-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Communicator Surgical Facemask with Clear Window is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech , Ltd.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152561. 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 Communicator Surgical Facemask with Clear Window?

Communicator Surgical Facemask with Clear Window is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Prestige Ameritech , Ltd.. The 510(k) number is K152561.

When did Communicator Surgical Facemask with Clear Window receive FDA 510(k) clearance?

Communicator Surgical Facemask with Clear Window received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152561.

Who is the listed applicant for Communicator Surgical Facemask with Clear Window?

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

What is the FDA product code for Communicator Surgical Facemask with Clear Window?

The FDA product code for Communicator Surgical Facemask with Clear Window is FXX.

Other records listing Prestige Ameritech , Ltd. 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.

K231741ProGear® Surgical Mask with Oxafence®, Model AV82030K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldK160100Prestige Ameritech Pediatric/Child’s Face mask

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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