FDA 510(k)

CryoDose V 50/50、175ml カシートキット、CryoDose V 50/50、236ml カシートキット

K番号: K210310 · 2021-10-22

決定日2021-10-22

製品コードGEH

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

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K210310. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Nuance Medical, LLC. The 510(k) number is K210310.

When did CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit receive FDA 510(k) clearance?

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit received FDA 510(k) clearance on 2021-10-22, under 510(k) number K210310.

Who is the listed applicant for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

The FDA 510(k) record lists Nuance Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

The FDA product code for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is GEH.

申請者としてNuance Medical, LLCを記載するその他の記録

K232674PainFreeze II K172203CryoDose TA OTC、霧状スプレー、CryoDose TA OTC、ストリームスプレー K162218Pain Freeze™、中流スプレー、モデルNo.2101；Pain Freeze™、ミストスプレー、モデルNo.2102 K161337CryoDose Hまたは同等

公式ソース

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