Cardiomemo
FDA 510(k) K803286 · Instromedix, Inc.
510(k) numberK803286
Submission
- Device name
- Cardiomemo
- Applicant
- Instromedix, Inc.
Walker, MI, US - Received
- December 30, 1980
- Decision date
- March 17, 1981
- 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 |
| 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 |
| K800696 | Electronic Pacemaker Waveform AnalyzerKRE · Traditional | Instromedix, Inc. | 08/14/1980SE |
More from Instromedix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010945 | Heartcard, Model 5258DXH · Traditional | 06/12/2001SE |
| K964408 | Poseidon Cardiac Monitoring System (PCMS)DPS · Traditional | 07/23/1997SE |
| K964036 | Cardiomagic 2000 SoftwareDXH · Traditional | 07/18/1997SE |
| K955060 | Accelerated Transmission ProtocolDXH · Traditional | 04/08/1996SE |
| K951096 | Lifesigns Receiving Cener 2000 Transtelephonic ReceiverDXH · Traditional | 01/16/1996SE |
| K945476 | Hearthwatch Iii(Tm)DXH · Traditional | 11/09/1995SE |
| K950003 | Cardiomagic(R) Software EnhancementsDXH · Traditional | 10/31/1995SE |
| K944362 | Heartcard Cardiac Event MonitorDXH · Traditional | 09/07/1995SE |
| K943931 | Carryall EnhancementsDXH · Traditional | 04/04/1995SE |
| K935586 | PrinceDXH · Traditional | 11/08/1994SE |
Questions and answers
When was Cardiomemo cleared by the FDA?
Cardiomemo (K803286) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 77 days after the submission was received.
What is the product code of K803286?
The FDA product code is KRE – Analyzer, Pacemaker Generator Function, Indirect, a Class II (moderate risk) device regulated under 21 CFR 870.3640.