FDA 510(k)

Sunkingdom 압박토너미터 SK-R, SK-T, SK-Q

K-번호: K191314 · 2019-12-19

신청자Chongqing Sunkingdom Medical Instrument Co., Ltd.

결정일2019-12-19

제품 코드HKY

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Sunkingdom Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K191314. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q?

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Chongqing Sunkingdom Medical Instrument Co., Ltd.. The 510(k) number is K191314.

When did Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q receive FDA 510(k) clearance?

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q received FDA 510(k) clearance on 2019-12-19, under 510(k) number K191314.

Who is the listed applicant for Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q?

The FDA 510(k) record lists Chongqing Sunkingdom Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q?

The FDA product code for Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q is HKY.

Chongqing Sunkingdom Medical Instrument Co., Ltd.를 신청인으로 등재한 기타 기록

K222787숱도름 완구학회眼科 초음파 검사 장비 SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P K182306숲의국가 슬릿 램프

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