FDA 510(k)

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes

K-번호: K183574 · 2019-09-06

결정일2019-09-06

제품 코드DPW

자문 위원회CV

결정Substantially Equivalent

기기 요약

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183574. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K183574.

When did SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes receive FDA 510(k) clearance?

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183574.

Who is the listed applicant for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

The FDA 510(k) record lists Huntleigh Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

The FDA product code for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is DPW.

Huntleigh Healthcare , Ltd.를 신청인으로 등재한 기타 기록

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