Paceview
FDA 510(k) K895535 · Micromedical
510(k) numberK895535
Submission
- Device name
- Paceview
- Applicant
- Micromedical
Gettysburg, PA, US - Received
- September 13, 1989
- Decision date
- March 19, 1990
- 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 |
| K870909 | Pacemaker Function AnalyzerKRE · Traditional | Paceart, Inc. | 04/27/1987SE |
| 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 |
|---|---|---|
| K974352 | Cardioview 3000 SoftwareLOS · Traditional | 09/08/1998SE |
| K974220 | Micromedical 12 Lead Simultaneous CableDPS · Traditional | 08/25/1998SE |
| K974351 | Biolog 3000 ElectrocardiographDPS · Traditional | 04/01/1998SE |
| K970305 | Printer InterfaceDXH · Traditional | 08/15/1997SE |
| K955891 | Cardioview Transtelephonic SoftwareDPS · Traditional | 10/08/1996SE |
| K895534 | BiologDRT · Traditional | 03/19/1990SE |
Questions and answers
When was Paceview cleared by the FDA?
Paceview (K895535) received a 510(k) decision of Substantially Equivalent on March 19, 1990, 187 days after the submission was received.
What is the product code of K895535?
The FDA product code is KRE – Analyzer, Pacemaker Generator Function, Indirect, a Class II (moderate risk) device regulated under 21 CFR 870.3640.