Analyzer, Pacemaker Generator Function, Indirect
This device is an indirect pacemaker generator function analyzer used externally to assess the performance of implanted pacemakers by analyzing telemetric data or surface signals, without direct device programming. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRE, regulated under 21 CFR 870.3640 within the Cardiovascular specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KRE
- Device Class
- FDA class 2
- Regulation Number
- 870.3640
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K110693 | PACEART OPTIMA SYSTEM SOFTWARE | Jun 08, 2011 | Substantially Equivalent | Medtronic, Inc. |
| K072950 | CYGNUS 12 LEAD ECG MODULE | Aug 22, 2008 | Substantially Equivalent | Cygnus, LLC |
| K032926 | EKG SPEAKS | Oct 15, 2003 | Substantially Equivalent | Medtronic Vascular |
| K922742 | HPM 40 HEART PACEMAKER MONITOR | Mar 18, 1993 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K915632 | PACEART CPTS-86/12 | Apr 14, 1992 | Substantially Equivalent | Paceart, Inc. |
| K895535 | PACEVIEW | Mar 19, 1990 | Substantially Equivalent | Micromedical |
| K870909 | PACEMAKER FUNCTION ANALYZER | Apr 27, 1987 | Substantially Equivalent | Paceart, Inc. |
| K833647 | PACEMAKER SYS ANALYZER #384 | Dec 16, 1983 | Substantially Equivalent | Pacesetter Systems |
| K832959 | PACEMAKER SYS. ANALYZER 378 | Nov 14, 1983 | Substantially Equivalent | Siemens Elema AB |
| K803286 | CARDIOMEMO | Mar 17, 1981 | Substantially Equivalent | Instromedix, Inc. |
| K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | Aug 14, 1980 | Substantially Equivalent | Instromedix, Inc. |
| K801022 | ULTRA-CHEK PACEMAKER MONITOR | Jun 17, 1980 | Substantially Equivalent | Powers Medical Systmes |
| K800782 | PACE-PULSE/COMPUTRAC | May 28, 1980 | Substantially Equivalent | Bib, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.