FDA 510(k)

3MP 모노크롬 디지털乳腺 X선 LCD 모니터 MS-S300

K-번호: K200161 · 2020-02-21

결정일2020-02-21

제품 코드PGY

자문 위원회RA

결정Substantially Equivalent

기기 요약

3MP Monochrome Digital Mammography LCD Monitor MS-S300 is the device name listed in this FDA 510(k) record. The listed applicant is Jvckenwood Corporation. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K200161. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 3MP Monochrome Digital Mammography LCD Monitor MS-S300?

3MP Monochrome Digital Mammography LCD Monitor MS-S300 is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Jvckenwood Corporation. The 510(k) number is K200161.

When did 3MP Monochrome Digital Mammography LCD Monitor MS-S300 receive FDA 510(k) clearance?

3MP Monochrome Digital Mammography LCD Monitor MS-S300 received FDA 510(k) clearance on 2020-02-21, under 510(k) number K200161.

Who is the listed applicant for 3MP Monochrome Digital Mammography LCD Monitor MS-S300?

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

What is the FDA product code for 3MP Monochrome Digital Mammography LCD Monitor MS-S300?

The FDA product code for 3MP Monochrome Digital Mammography LCD Monitor MS-S300 is PGY.

Jvckenwood Corporation를 신청인으로 등재한 기타 기록

K2411053MP 컬러 LCD 모니터 (CL-S301)K2228648MP 컬러 LCD 모니터 CL-R813 K2129856MP Color LCD Monitor CL-S600 K20373312MP 컬러 디지털 마ammography LCD 모니터 CL-S1200 K2103452MP 모노크롬 LCD 모니터 MS-S200 K1911375MP 컬러 LCD 모니터 CL-S500, 5MP 모노크롬 LCD 모니터 MS-S500

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