FDA 510(k)

t:slim X2 Insulin Pump with Interoperable Technology

K-번호: K232380 · 2023-11-03

결정일2023-11-03

제품 코드QFG

자문 위원회CH [기업명]의 [제품명]은 미국 식품의약국(FDA)에서 510(k) 등록을 완료한 의료기기입니다. 이 제품은 [PMA] 및 [NCT] 등록을 완료하였으며, [PMID]로 확인할 수 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL].

결정Substantially Equivalent

기기 요약

t:slim X2 Insulin Pump with Interoperable Technology is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K232380. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the t:slim X2 Insulin Pump with Interoperable Technology?

t:slim X2 Insulin Pump with Interoperable Technology is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K232380.

When did t:slim X2 Insulin Pump with Interoperable Technology receive FDA 510(k) clearance?

t:slim X2 Insulin Pump with Interoperable Technology received FDA 510(k) clearance on 2023-11-03, under 510(k) number K232380.

Who is the listed applicant for t:slim X2 Insulin Pump with Interoperable Technology?

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

What is the FDA product code for t:slim X2 Insulin Pump with Interoperable Technology?

The FDA product code for t:slim X2 Insulin Pump with Interoperable Technology is QFG.

Tandem Diabetes Care, Inc.를 신청인으로 등재한 기타 기록

K260429컨트롤-아이퀸+ 기술 K253074Tandem Mobi insulin pump with interoperable technology K250792t:slim X2 insulin pump with interoperable technology K250798컨트롤-아이퀸+ 기술 K243823컨트롤-아이퀸+ 기술 K241078Tandem Mobi Insulin Pump with interoperable technology

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