FDA 510(k)

MPR2 로고 데이터 로거

K-번호: K171666 · 2017-07-06

결정일2017-07-06

제품 코드GWM

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

MPR2 logO DATALOGGER is the device name listed in this FDA 510(k) record. The listed applicant is Raumedic AG. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K171666. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MPR2 logO DATALOGGER?

MPR2 logO DATALOGGER is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Raumedic AG. The 510(k) number is K171666.

When did MPR2 logO DATALOGGER receive FDA 510(k) clearance?

MPR2 logO DATALOGGER received FDA 510(k) clearance on 2017-07-06, under 510(k) number K171666.

Who is the listed applicant for MPR2 logO DATALOGGER?

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

What is the FDA product code for MPR2 logO DATALOGGER?

The FDA product code for MPR2 logO DATALOGGER is GWM.

Raumedic AG를 신청인으로 등재한 기타 기록

K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLT

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