Cleared Traditional

K142932 - Deltex Medical KDP72 Doppler Probe
(FDA 510(k) Clearance)

K142932 · Deltex Medical Limited · Cardiovascular

Jan 2015

Decision

105d

Days

Class 2

Risk

K142932 is an FDA 510(k) clearance for the Deltex Medical KDP72 Doppler Probe. This device is classified as a Probe, Blood-flow, Extravascular (Class II — Special Controls, product code DPT).

Submitted by Deltex Medical Limited (Chichester, West Sussex, GB). The FDA issued a Cleared decision on January 22, 2015, 105 days after receiving the submission on October 9, 2014.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2120.

Submission Details

510(k) Number	K142932 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2014
Decision Date	January 22, 2015
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF