FDA PMA

Pump, infusion, insulin, to be used with invasive glucose sensor

PMA 번호: P140015 · 2019-12-19

신청자Tandem Diabetes Care, Inc.

결정일2019-12-19

PMA 번호P140015

제품 코드OYC

의료기기 등급등급 3

의학적 전문분야U

자문 위원회CH

기기 요약

Pump, infusion, insulin, to be used with invasive glucose sensor 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 2019-12-19. The device is classified under product code OYC. It was reviewed by the CH advisory panel.

자주 묻는 질문

What is the Pump, infusion, insulin, to be used with invasive glucose sensor?

Pump, infusion, insulin, to be used with invasive glucose sensor is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Tandem Diabetes Care, Inc..

When did Pump, infusion, insulin, to be used with invasive glucose sensor receive FDA 510(k) clearance?

The clearance date for Pump, infusion, insulin, to be used with invasive glucose sensor can be found in the official FDA records.

Who is the listed applicant for Pump, infusion, insulin, to be used with invasive glucose sensor?

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 Pump, infusion, insulin, to be used with invasive glucose sensor?

The FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor is OYC.

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