FDA 510(k)

Exsalta

K-번호: K221676 · 2022-09-16

결정일2022-09-16

제품 코드BTA

자문 위원회SU

결정Substantially Equivalent

기기 요약

Exsalta is the device name listed in this FDA 510(k) record. The listed applicant is Drw Medical. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K221676. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Exsalta?

Exsalta is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Drw Medical. The 510(k) number is K221676.

When did Exsalta receive FDA 510(k) clearance?

Exsalta received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221676.

Who is the listed applicant for Exsalta?

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

What is the FDA product code for Exsalta?

The FDA product code for Exsalta is BTA.

관련 기기 (코드: BTA)

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관련 기기 (코드: BTA)

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