FDA 510(k)

ASSURE 웨어러블 ECG

K-번호: K233864 · 2024-05-07

결정일2024-05-07

제품 코드MWJ

자문 위원회CV

결정Substantially Equivalent

기기 요약

ASSURE Wearable ECG is the device name listed in this FDA 510(k) record. The listed applicant is Kestra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K233864. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ASSURE Wearable ECG?

ASSURE Wearable ECG is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Kestra Medical Technologies, Inc.. The 510(k) number is K233864.

When did ASSURE Wearable ECG receive FDA 510(k) clearance?

ASSURE Wearable ECG received FDA 510(k) clearance on 2024-05-07, under 510(k) number K233864.

Who is the listed applicant for ASSURE Wearable ECG?

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

What is the FDA product code for ASSURE Wearable ECG?

The FDA product code for ASSURE Wearable ECG is MWJ.

관련 기기 (코드: MWJ)

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관련 기기 (코드: MWJ)

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