KREClass II
Analyzer, Pacemaker Generator Function, Indirect
Cardiovascular · 21 CFR 870.3640
MDR events43All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances13All time
Recent MDR events
43 adverse event reports on file
- ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECTAug 12, 2023MalfunctionMedtronicMW5135205
- ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECTAug 12, 2023MalfunctionMedtronicMW5136629
- PACEART OPTIMA SYSTEM SOFTWAREJun 30, 2022MalfunctionMedtronic, Inc.2182208-2022-02107
- PACEART OPTIMA SYSTEM SOFTWAREJun 23, 2022MalfunctionMedtronic, Inc.2182208-2022-02018
- PACEART OPTIMA SYSTEM SOFTWAREDec 21, 2021MalfunctionMedtronic, Inc.2182208-2021-05016
- PACEART OPTIMA SYSTEM SOFTWAREDec 3, 2021MalfunctionMedtronic, Inc.2182208-2021-04736
- PACEART OPTIMA SYSTEM SOFTWARENov 17, 2021MalfunctionMedtronic, Inc.2182208-2021-04528
- PACEART OPTIMA SYSTEM SOFTWAREOct 21, 2021MalfunctionMedtronic, Inc.2182208-2021-04191
- PACEART OPTIMA SYSTEM SOFTWARESep 14, 2021MalfunctionMedtronic, Inc.2182208-2021-03594
- PACEART OPTIMA SYSTEM SOFTWARESep 9, 2021MalfunctionMedtronic, Inc.2182208-2021-03555
Event type breakdown
Malfunction43
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
13 clearances for this product code
- Medtronic, Inc.Jun 8, 2011
K110693 · PACEART OPTIMA SYSTEM SOFTWARE
- Cygnus, LLCAug 22, 2008
K072950 · CYGNUS 12 LEAD ECG MODULE
- Medtronic VascularOct 15, 2003
K032926 · EKG SPEAKS
- Biotronik, GmbH & Co.Mar 18, 1993
K922742 · HPM 40 HEART PACEMAKER MONITOR
- Paceart, Inc.Apr 14, 1992
K915632 · PACEART CPTS-86/12
- MicromedicalMar 19, 1990
K895535 · PACEVIEW
- Paceart, Inc.Apr 27, 1987
K870909 · PACEMAKER FUNCTION ANALYZER
- Pacesetter SystemsDec 16, 1983
K833647 · PACEMAKER SYS ANALYZER #384