Cleared Traditional

LIFEDOP MODEL 300ABI

K093393 · Summit Doppler Systems, Inc. · Radiology
Dec 2009
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K093393 is an FDA 510(k) clearance for the LIFEDOP MODEL 300ABI, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on December 24, 2009, 55 days after receiving the submission on October 30, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K093393 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2009
Decision Date December 24, 2009
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540