FDA 510(k)

Sotair Device

K-번호: K212905 · 2022-08-18

결정일2022-08-18

제품 코드BTM

자문 위원회AN

결정Substantially Equivalent

기기 요약

Sotair Device is the device name listed in this FDA 510(k) record. The listed applicant is Safe Bvm Corporation. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K212905. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sotair Device?

Sotair Device is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is Safe Bvm Corporation. The 510(k) number is K212905.

When did Sotair Device receive FDA 510(k) clearance?

Sotair Device received FDA 510(k) clearance on 2022-08-18, under 510(k) number K212905.

Who is the listed applicant for Sotair Device?

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

What is the FDA product code for Sotair Device?

The FDA product code for Sotair Device is BTM.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

Sotair Device

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BTM)

공식 출처