FDA 510(k)

핫도그 와arming 침대 + 반환 전극

K-번호: K210727 · 2022-02-01

신청자Augustine Temperature Management, LLC

결정일2022-02-01

제품 코드GEI

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

HotDog Warming Mattress + Return Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Temperature Management, LLC. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K210727. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Augustine Temperature Management, LLC. The 510(k) number is K210727.

When did HotDog Warming Mattress + Return Electrode receive FDA 510(k) clearance?

HotDog Warming Mattress + Return Electrode received FDA 510(k) clearance on 2022-02-01, under 510(k) number K210727.

Who is the listed applicant for HotDog Warming Mattress + Return Electrode?

The FDA 510(k) record lists Augustine Temperature Management, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HotDog Warming Mattress + Return Electrode?

The FDA product code for HotDog Warming Mattress + Return Electrode is GEI.

Augustine Temperature Management, LLC를 신청인으로 등재한 기타 기록

K232627핫도그 와arming 침대 + 반환 전극 K230866핫도그 와arming 침대 + 반환 전극

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