510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K042177Substantially Equivalent

Modification to Mac 5000 ECG Analysis System

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

K042177 is the FDA 510(k) clearance record for MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DPS (Electrocardiograph). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K042177.

Clearance record

Decision date
Received
(16 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
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 DPS

Trailing 12 months
7 clearances under product code DPS in the twelve months to November 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20262
November 20260