510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001305Substantially Equivalent

Mac-Lab System and Cardiolab Ep System

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

K001305 is the FDA 510(k) clearance record for MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM, a class II device, cleared for General Electric Medical Systems Information Techn on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 33 510(k) clearances for General Electric Medical Systems Information Techn, from to . As of , FDA records show no recalls naming K001305.

Clearance record

Decision date
Received
(64 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
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 DQK

Trailing 12 months
25 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20260