510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860621Substantially Equivalent

1Mhz Cw Doppler Transducer W/lily Antepartum #507

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

K860621 is the FDA 510(k) clearance record for 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507, a class II device, cleared for Impex Medical Systems, Inc. on under FDA product code HGL (Transducer, Ultrasonic, Obstetric). FDA records list one 510(k) clearance for Impex Medical Systems, Inc. As of , FDA records show no recalls naming K860621.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HGL Transducer, Ultrasonic, Obstetric
Regulation
21 CFR 884.2960
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Impex Medical Systems, Inc. 6355 Joyce Dr., Golden CO
Third party review
No

Clearances, product code HGL

Trailing 12 months

FDA records hold no clearances under product code HGL in the trailing twelve months.

FDA records show no clearances under product code HGL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260