FDA 510(k)

모델 3543A, 4343A, 2929A 및 A843B

K-번호: K170480 · 2017-07-07

신청자Shanghai PZ Medical Technolgoy Co., Ltd.

결정일2017-07-07

제품 코드MQB

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Models 3543A, 4343A, 2929A and A843B is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai PZ Medical Technolgoy Co., Ltd.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K170480. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Models 3543A, 4343A, 2929A and A843B?

Models 3543A, 4343A, 2929A and A843B is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Shanghai PZ Medical Technolgoy Co., Ltd.. The 510(k) number is K170480.

When did Models 3543A, 4343A, 2929A and A843B receive FDA 510(k) clearance?

Models 3543A, 4343A, 2929A and A843B received FDA 510(k) clearance on 2017-07-07, under 510(k) number K170480.

Who is the listed applicant for Models 3543A, 4343A, 2929A and A843B?

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

What is the FDA product code for Models 3543A, 4343A, 2929A and A843B?

The FDA product code for Models 3543A, 4343A, 2929A and A843B is MQB.

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모델 3543A, 4343A, 2929A 및 A843B

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MQB)

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