FDA 510(k)

カーディナルヘルスロイヤルシルク手術衣、カーディナルヘルスロイヤルシルクスクリブ看護師衣

K番号: K211765 · 2021-11-23

決定日2021-11-23

製品コードFYA

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

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, LLC. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K211765. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown?

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Cardinal Health, LLC. The 510(k) number is K211765.

When did Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown receive FDA 510(k) clearance?

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211765.

Who is the listed applicant for Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown?

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

What is the FDA product code for Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown?

The FDA product code for Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown is FYA.

申請者としてCardinal Health, LLCを記載するその他の記録

公式ソース

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