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FDA 510(k)

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

K-Number: K183574 · 2019-09-06

ApplicantHuntleigh Healthcare , Ltd.
Decision Date2019-09-06
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Huntleigh Healthcare , Ltd.. The 510(k) number is K183574.

When was SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes approved by the FDA?

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

What company makes SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is manufactured by Huntleigh Healthcare , Ltd..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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