Cleared Abbreviated

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

K183574 · Huntleigh Healthcare , Ltd. · Cardiovascular
Sep 2019
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K183574 is an FDA 510(k) clearance for the SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes, a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW), submitted by Huntleigh Healthcare , Ltd. (Cardiff, GB). The FDA issued a Cleared decision on September 6, 2019, 259 days after receiving the submission on December 21, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number K183574 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2018
Decision Date September 06, 2019
Days to Decision 259 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPW — Flowmeter, Blood, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2100

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