510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K062976Substantially Equivalent

Modification to Cic Pro Clinical Information Center

GE Medical Systems Information Technologies, Inc., Milwaukee WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062976 is the FDA 510(k) clearance record for MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show 4 recalls naming K062976.

Clearance record

Decision date
Received
(168 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Ge Medical Systems Information Technologies 8200 W. Tower Ave., Milwaukee WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI 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 DSI, 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