Imexdop Ct+

FDA 510(k) K942441 · Imex Medical Systems, Inc.

Substantially Equivalent

510(k) numberK942441

Submission

Device name
Imexdop Ct+
Applicant
Imex Medical Systems, Inc.
Golden, CO, US
Received
May 23, 1994
Decision date
August 23, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAF – Monitor, Ultrasonic, Nonfetal
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1540
Specialty
Radiology

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More from Multigon Industries, Inc.

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K942243Imex 8000 Personal Cascular LabIYO · Traditional 11/03/1995SE
K944196Imwxdop IrJAF · Traditional 05/12/1995SE
K910462Pocket Dop 3HEP · Traditional 06/24/1991SE
K901593Imex Dop-Tone IIKNG · Traditional 07/02/1990SE
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Questions and answers

When was Imexdop Ct+ cleared by the FDA?

Imexdop Ct+ (K942441) received a 510(k) decision of Substantially Equivalent on August 23, 1994, 92 days after the submission was received.

What is the product code of K942441?

The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.