510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992811Substantially Equivalent

Transducers for Ultrasound and Tocodynamometer Fetal Monitoring

Epic Medical Equipment Services, Inc., Plano TX / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K992811 is the FDA 510(k) clearance record for TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING, a class II device, cleared for Epic Medical Equipment Services, Inc. on under FDA product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)). FDA records list 13 510(k) clearances for Epic Medical Equipment Services, Inc., from to . As of , FDA records show no recalls naming K992811.

Clearance record

Decision date
Received
(151 days to decision)
Product code
HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Regulation
21 CFR 884.2720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Epic Medical Equipment Services, Inc. 1800 10th St., Suite 300, Plano TX
510(k) summary
Summary
Third party review
No

Clearances, product code HFM

Trailing 12 months

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

FDA records show no clearances under product code HFM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFM, 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