FDA 510(k)

Neteera 130H/131H Vital Sign Monitoring Sensor

K-번호: K212143 · 2022-09-28

결정일2022-09-28

제품 코드DRT

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정Substantially Equivalent

기기 요약

Neteera 130H/131H Vital Sign Monitoring Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Neteera Technologies , Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K212143. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Neteera 130H/131H Vital Sign Monitoring Sensor?

Neteera 130H/131H Vital Sign Monitoring Sensor is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Neteera Technologies , Ltd.. The 510(k) number is K212143.

When did Neteera 130H/131H Vital Sign Monitoring Sensor receive FDA 510(k) clearance?

Neteera 130H/131H Vital Sign Monitoring Sensor received FDA 510(k) clearance on 2022-09-28, under 510(k) number K212143.

Who is the listed applicant for Neteera 130H/131H Vital Sign Monitoring Sensor?

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

What is the FDA product code for Neteera 130H/131H Vital Sign Monitoring Sensor?

The FDA product code for Neteera 130H/131H Vital Sign Monitoring Sensor is DRT.

Neteera Technologies , Ltd.를 신청인으로 등재한 기타 기록

K231733Neteera 130H-Plus Vital Sign Monitoring Sensor

공식 출처

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