FDA 510(k)

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

Numéro K : K171162 · 2017-08-15

Date de décision2017-08-15

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K171162. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield?

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is Prestige Ameritech. The 510(k) number is K171162.

When did Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield receive FDA 510(k) clearance?

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield received FDA 510(k) clearance on 2017-08-15, under 510(k) number K171162.

Who is the listed applicant for Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield?

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

What is the FDA product code for Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield?

The FDA product code for Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield is FXX.

Essais cliniques associés

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Autres dossiers indiquant Prestige Ameritech en tant que demandeur

K231741ProGear® Surgical Mask with Oxafence®, Model AV82030 K160100Prestige Ameritech Pediatric/Child’s Face mask

Dispositifs connexes (Code : FXX)

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.

Source officielle

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