FDA 510(k)

POGO 자동 혈당 모니터링 시스템

K-번호: K162203 · 2017-04-06

결정일2017-04-06

제품 코드NBW

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].

결정대체적으로 동일

기기 요약

POGO Automatic Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Intuity Medical, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K162203. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the POGO Automatic Blood Glucose Monitoring System?

POGO Automatic Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Intuity Medical, Inc.. The 510(k) number is K162203.

When did POGO Automatic Blood Glucose Monitoring System receive FDA 510(k) clearance?

POGO Automatic Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162203.

Who is the listed applicant for POGO Automatic Blood Glucose Monitoring System?

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

What is the FDA product code for POGO Automatic Blood Glucose Monitoring System?

The FDA product code for POGO Automatic Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Intuity Medical, Inc.를 신청인으로 등재한 기타 기록

K181316POGO 자동 혈당 모니터링 시스템 K152493POGO 자동 혈당 모니터링 시스템

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.