510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901593Substantially Equivalent

Imex Dop-Tone II

Imex Medical Systems, Inc., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901593 is the FDA 510(k) clearance record for IMEX DOP-TONE II, a class II device, cleared for Imex Medical Systems, Inc. on under FDA product code KNG (Monitor, Ultrasonic, Fetal). FDA records list 19 510(k) clearances for Imex Medical Systems, Inc., from to . As of , FDA records show no recalls naming K901593.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KNG Monitor, Ultrasonic, Fetal
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Imex Medical Systems, Inc. 6355 Joyce Dr., Golden CO
Third party review
No

Clearances, product code KNG

Trailing 12 months
1 clearance under product code KNG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260