510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110556Substantially Equivalent

Mini Telemetry System

Wipro GE Healthcare Private Ltd., Laurel MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110556 is the FDA 510(k) clearance record for MINI TELEMETRY SYSTEM, a class II device, cleared for Wipro GE Healthcare Private, Ltd. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 5 510(k) clearances for Wipro GE Healthcare Private, Ltd., from to . As of , FDA records show no recalls naming K110556.

Clearance record

Decision date
Received
(141 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Wipro GE Healthcare Private, Ltd. 8880 Goman Rd., Laurel MD
510(k) summary
Summary PDF
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