510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K042782Substantially Equivalent

Seer Mc

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

K042782 is the FDA 510(k) clearance record for SEER MC, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K042782.

Clearance record

Decision date
Received
(331 days to decision)
Product code
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation
21 CFR 870.2800
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 MLO

Trailing 12 months
1 clearance under product code MLO in the twelve months to November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260