FDA 510(k)

Cocoon Solo (DX-7020s)

K-번호: K250687 · 2025-10-24

결정일2025-10-24

제품 코드MUH

자문 위원회DE

결정Substantially Equivalent

기기 요약

Cocoon Solo (DX-7020s) is the device name listed in this FDA 510(k) record. The listed applicant is Dexcowin Global, Inc.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K250687. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Cocoon Solo (DX-7020s)?

Cocoon Solo (DX-7020s) is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Dexcowin Global, Inc.. The 510(k) number is K250687.

When did Cocoon Solo (DX-7020s) receive FDA 510(k) clearance?

Cocoon Solo (DX-7020s) received FDA 510(k) clearance on 2025-10-24, under 510(k) number K250687.

Who is the listed applicant for Cocoon Solo (DX-7020s)?

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

What is the FDA product code for Cocoon Solo (DX-7020s)?

The FDA product code for Cocoon Solo (DX-7020s) is MUH.

공식 출처

FDA 데이터베이스에서 보기 →

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

Cocoon Solo (DX-7020s)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MUH)

공식 출처