FDA 510(k)

手術用耳紐付顔面マスク（下端開口シールド付き）および手術用留め具付顔面マスク（下端開口シールド付き）

K番号: K171162 · 2017-08-15

決定日2017-08-15

製品コードFXX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてPrestige Ameritechを記載するその他の記録

K231741ProGear®手術用マスクｏｘａｆｅｎｃ®、モデルAV82030 K160100プレステージ・アメリテック小児/子供用フェースマスク

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