Cleared Traditional

POCKET DOP 3

K910462 · Imex Medical Systems, Inc. · Radiology

Jun 1991

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K910462 is an FDA 510(k) clearance for the POCKET DOP 3, a Monitor, Blood-flow, Ultrasonic (Class II — Special Controls, product code HEP), submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on June 24, 1991, 140 days after receiving the submission on February 4, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number	K910462 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1991
Decision Date	June 24, 1991
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—