510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K060307Substantially Equivalent

12 Rl Algorithm

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

K060307 is the FDA 510(k) clearance record for 12 RL ALGORITHM, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K060307.

Clearance record

Decision date
Received
(178 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
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 DRT

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