510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983395Substantially Equivalent

Fetalgard 3000 Fetal Monitor

Analogic Corp., Peabody MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983395 is the FDA 510(k) clearance record for FETALGARD 3000 FETAL MONITOR, a class II device, cleared for Analogic Corp. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 39 510(k) clearances for Analogic Corp., from to . As of , FDA records show no recalls naming K983395.

Clearance record

Decision date
Received
(321 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Analogic Corp. 8 Centennial Dr., Peabody MA
510(k) summary
Summary
Third party review
No

Clearances, product code HGM

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