FDA 510(k)

Circa S-Cath M 식도 온도探头 및 온도 모니터링 시스템

K-번호: K200943 · 2021-12-17

결정일2021-12-17

제품 코드FLL

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, LLC. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K200943. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Circa Scientific, LLC. The 510(k) number is K200943.

When did Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System receive FDA 510(k) clearance?

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2021-12-17, under 510(k) number K200943.

Who is the listed applicant for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

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

What is the FDA product code for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

The FDA product code for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System is FLL.

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Circa S-Cath M 식도 온도探头 및 온도 모니터링 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FLL)

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