EKG Speaks
FDA 510(k) K032926 · Medtronic Vascular
510(k) numberK032926
Submission
- Device name
- EKG Speaks
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- September 22, 2003
- Decision date
- October 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 |
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Questions and answers
When was EKG Speaks cleared by the FDA?
EKG Speaks (K032926) received a 510(k) decision of Substantially Equivalent on October 15, 2003, 23 days after the submission was received.
What is the product code of K032926?
The FDA product code is KRE – Analyzer, Pacemaker Generator Function, Indirect, a Class II (moderate risk) device regulated under 21 CFR 870.3640.