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
K000645Substantially Equivalent

Ge Marquette Medical Systems Prucka Cardiolab Cath System, Version 1.11

General Electric Medical Systems Information Techn, Sugarland TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000645 is the FDA 510(k) clearance record for GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11, a class II device, cleared for General Electric Medical Systems Information Techn on under FDA product code DPS (Electrocardiograph). FDA records list 33 510(k) clearances for General Electric Medical Systems Information Techn, from to . As of , FDA records show no recalls naming K000645.

Clearance record

Decision date
Received
(89 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
General Electric Medical Systems Information Techn 13000 Executive Dr., Sugarland TX
510(k) summary
Summary
Third party review
No

Clearances, product code DPS

Trailing 12 months
5 clearances under product code DPS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260