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FDA 510(k)

PRESTIGE AMERITECH FACE MASK

K-Number: K061716 · 2006-08-14

ApplicantPrestige Ameritech
Decision Date2006-08-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRESTIGE AMERITECH FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech. It received FDA 510(k) clearance on 2006-08-14 under 510(k) number K061716. 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 PRESTIGE AMERITECH FACE MASK?

PRESTIGE AMERITECH FACE MASK is a medical device that received FDA 510(k) clearance on 2006-08-14. The listed applicant is Prestige Ameritech. The 510(k) number is K061716.

When did PRESTIGE AMERITECH FACE MASK receive FDA 510(k) clearance?

PRESTIGE AMERITECH FACE MASK received FDA 510(k) clearance on 2006-08-14, under 510(k) number K061716.

Who is the listed applicant for PRESTIGE AMERITECH FACE MASK?

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 PRESTIGE AMERITECH FACE MASK?

The FDA product code for PRESTIGE AMERITECH FACE MASK 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 Prestige Ameritech 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 maskK102092PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES

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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