Pacemaker Function Analyzer
FDA 510(k) K870909 · Paceart, Inc.
510(k) numberK870909
Submission
- Device name
- Pacemaker Function Analyzer
- Applicant
- Paceart, Inc.
Millburn, NJ, US - Received
- March 5, 1987
- Decision date
- April 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRE – Analyzer, Pacemaker Generator Function, Indirect
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3640
- Specialty
- Cardiovascular
Other 510(k)s with product code KRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110693 | Paceart Optima System SoftwareKRE · Traditional | Medtronic, Inc. | 06/08/2011SE |
| K072950 | Cygnus 12 Lead ECG ModuleKRE · Traditional | Cygnus, LLC | 08/22/2008SE |
| K032926 | EKG SpeaksKRE · Special | Medtronic Vascular | 10/15/2003SE |
| K922742 | HPM 40 Heart Pacemaker MonitorKRE · Traditional | Biotronik, GmbH & Co. | 03/18/1993SE |
| K915632 | Paceart CPTS-86/12KRE · Traditional | Paceart, Inc. | 04/14/1992SE |
| K895535 | PaceviewKRE · Traditional | Micromedical | 03/19/1990SE |
| K833647 | Pacemaker Sys Analyzer #384KRE · Traditional | Pacesetter Systems | 12/16/1983SE |
| K832959 | Pacemaker Sys. Analyzer 378KRE · Traditional | Siemens Elema AB | 11/14/1983SE |
| K803286 | CardiomemoKRE · Traditional | Instromedix, Inc. | 03/17/1981SE |
| K800696 | Electronic Pacemaker Waveform AnalyzerKRE · Traditional | Instromedix, Inc. | 08/14/1980SE |
More from Instromedix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012407 | Paceart TX3 Cardiac Event RecorderDXH · Special | 08/14/2001SE |
| K982090 | Paceart Home Trak Plus Easi Event Recorder SystemDXH · Traditional | 01/26/1999SE |
| K973141 | Heart Access Plus Cardiac Event RecorderDXH · Traditional | 11/12/1997SE |
| K960721 | Paceart Wrist ElectrodesDRX · Traditional | 07/18/1996SE |
| K952065 | Paceart CardiovoiceDXH · Traditional | 01/16/1996SE |
| K931296 | Paceart CardiophoneDXH · Traditional | 10/01/1993SE |
| K915632 | Paceart CPTS-86/12KRE · Traditional | 04/14/1992SE |
| K880283 | Paceart Pacemaker Patient Test Syst/Tel Opt CPTSDXH · Traditional | 03/09/1988SE |
Questions and answers
When was Pacemaker Function Analyzer cleared by the FDA?
Pacemaker Function Analyzer (K870909) received a 510(k) decision of Substantially Equivalent on April 27, 1987, 53 days after the submission was received.
What is the product code of K870909?
The FDA product code is KRE – Analyzer, Pacemaker Generator Function, Indirect, a Class II (moderate risk) device regulated under 21 CFR 870.3640.