510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K111200Substantially Equivalent

Mac-Lab System, Cardiolab System, Combolab System, Specialslab System

GE Healthcare, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111200 is the FDA 510(k) clearance record for MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM, a class II device, cleared for GE Healthcare on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 888 510(k) clearances for GE Healthcare, from to . As of , FDA records show no recalls naming K111200.

Clearance record

Decision date
Received
(166 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
GE Healthcare 8200 W. Tower Ave., Milwaukee WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

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