FDA 510(k)

740 SafeSAT

K-번호: K200160 · 2021-02-15

결정일2021-02-15

제품 코드MWI

자문 위원회CV

결정Substantially Equivalent

기기 요약

740 SafeSAT is the device name listed in this FDA 510(k) record. The listed applicant is Zoe Medical, Inc.. It received FDA 510(k) clearance on 2021-02-15 under 510(k) number K200160. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 740 SafeSAT?

740 SafeSAT is a medical device that received FDA 510(k) clearance on 2021-02-15. The listed applicant is Zoe Medical, Inc.. The 510(k) number is K200160.

When did 740 SafeSAT receive FDA 510(k) clearance?

740 SafeSAT received FDA 510(k) clearance on 2021-02-15, under 510(k) number K200160.

Who is the listed applicant for 740 SafeSAT?

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

What is the FDA product code for 740 SafeSAT?

The FDA product code for 740 SafeSAT is MWI.

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740 SafeSAT

기기 요약

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관련 임상시험

관련 기기 (코드: MWI)

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