Imex Dop-Tone II

FDA 510(k) K901593 · Imex Medical Systems, Inc.

Substantially Equivalent

510(k) numberK901593

Submission

Device name
Imex Dop-Tone II
Applicant
Imex Medical Systems, Inc.
Golden, CO, US
Received
April 5, 1990
Decision date
July 2, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNG – Monitor, Ultrasonic, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

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Questions and answers

When was Imex Dop-Tone II cleared by the FDA?

Imex Dop-Tone II (K901593) received a 510(k) decision of Substantially Equivalent on July 2, 1990, 88 days after the submission was received.

What is the product code of K901593?

The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.