Cleared Traditional

LIFEDOP MODEL, L350R

K090499 · Summit Doppler Systems, Inc. · Radiology

Mar 2009

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K090499 is an FDA 510(k) clearance for the LIFEDOP MODEL, L350R, a Monitor, Fetal Doppler Ultrasound (Class II — Special Controls, product code MAA), submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on March 31, 2009, 34 days after receiving the submission on February 25, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number	K090499 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2009
Decision Date	March 31, 2009
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF