510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991735Substantially Equivalent

Mac Series Electrocardiographs Including Mac 5000, Mac Pc, Mac 6, Mac Vu, Mac 8 Electrocardiographs

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

K991735 is the FDA 510(k) clearance record for MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS, cleared for General Electric Medical Systems Information Techn on under FDA product code LOS. FDA records list 33 510(k) clearances for General Electric Medical Systems Information Techn, from to . As of , FDA records show no recalls naming K991735.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LOS
Review panel
Unknown
Applicant
General Electric Medical Systems Information Techn 8200 W. Tower Ave., Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code LOS

Trailing 12 months

FDA records hold no clearances under product code LOS in the trailing twelve months.

FDA records show no clearances under product code LOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260