Cleared Traditional

K973336 - IMEX STETHODOP
(FDA 510(k) Clearance)

K973336 · Imex Medical Systems, Inc. · Radiology device

Feb 1998

Decision

154d

Days

Class 2

Risk

K973336 is an FDA 510(k) clearance for the IMEX STETHODOP. This device is classified as a Monitor, Ultrasonic, Nonfetal (Class II - Special Controls, product code JAF).

Submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on February 5, 1998, 154 days after receiving the submission on September 4, 1997.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number	K973336 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 04, 1997
Decision Date	February 05, 1998
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement