FDA 510(k)

헬스-이-커넥트 시스템(IDA와 함께)

K-번호: K163664 · 2017-09-18

결정일2017-09-18

제품 코드NDC

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

Health-e-Connect System with IDA is the device name listed in this FDA 510(k) record. The listed applicant is Alr Technologies. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K163664. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Health-e-Connect System with IDA?

Health-e-Connect System with IDA is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Alr Technologies. The 510(k) number is K163664.

When did Health-e-Connect System with IDA receive FDA 510(k) clearance?

Health-e-Connect System with IDA received FDA 510(k) clearance on 2017-09-18, under 510(k) number K163664.

Who is the listed applicant for Health-e-Connect System with IDA?

The FDA 510(k) record lists Alr Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Health-e-Connect System with IDA?

The FDA product code for Health-e-Connect System with IDA is NDC.

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헬스-이-커넥트 시스템(IDA와 함께)

기기 요약

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관련 임상시험

관련 기기 (코드: NDC)

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