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PMA 번호: P130007 · 2018-07-11

결정일2018-07-11

PMA 번호P130007

제품 코드OYC

의료기기 등급등급 3

의학적 전문분야U

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].

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 Animas Corp.. It received FDA 510(k) clearance on 2018-07-11. 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 2018-07-11. The listed applicant is Animas Corp..

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 Animas Corp. 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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