510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833647Substantially Equivalent

Pacemaker Sys Analyzer #384

Pacesetter Systems, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833647 is the FDA 510(k) clearance record for PACEMAKER SYS ANALYZER #384, a class II device, cleared for Pacesetter Systems on under FDA product code KRE (Analyzer, Pacemaker Generator Function, Indirect). FDA records list 96 510(k) clearances for Pacesetter Systems, from to . As of , FDA records show no recalls naming K833647.

Clearance record

Decision date
Received
(60 days to decision)
Product code
KRE Analyzer, Pacemaker Generator Function, Indirect
Regulation
21 CFR 870.3640
Device class
Class II
Review panel
Cardiovascular
Applicant
Pacesetter Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KRE

Trailing 12 months

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

FDA records show no clearances under product code KRE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KRE, 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