Pacemaker Sys Analyzer #384
FDA 510(k) K833647 · Pacesetter Systems
510(k) numberK833647
Submission
- Device name
- Pacemaker Sys Analyzer #384
- Applicant
- Pacesetter Systems
Mchenry, IL, US - Received
- October 17, 1983
- Decision date
- December 16, 1983
- 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 |
| 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 |
|---|---|---|
| K910924 | Endocardial Leads-Mod. to the PolyvinylpyrrolidoneDTB · Traditional | 08/28/1991SE |
| K902147 | Endocardial Screw-In Lead Model 1028TDTB · Traditional | 07/17/1990SE |
| K900512 | Siemens Elema Models 4020T and 4021T AdaptersDTD · Traditional | 06/25/1990SE |
| K900550 | Fast-Pass Ace Models 1212T/1222T/1216T/1226TDTB · Traditional | 04/20/1990SE |
| K895447 | Endocardial Screw-In Lead Model 1020TDTB · Traditional | 12/20/1989SE |
| K891905 | Cardiovascular Permanent Pacemaker ElectrodeDTB · Traditional | 06/05/1989SE |
| K885267 | VS-1 Model Number 251K Pulse GeneratorDXY · Traditional | 03/28/1989SE |
| K890547 | Siemens Elema Models 4025 and 4026 AdaptersDTB · Traditional | 03/22/1989SE |
| K884733 | Afp Model 262T Pulse GeneratorDXY · Traditional | 02/10/1989SE |
| K883087 | Prolog MP 658M Pulse GeneratorDXY · Traditional | 09/14/1988SE |
Questions and answers
When was Pacemaker Sys Analyzer #384 cleared by the FDA?
Pacemaker Sys Analyzer #384 (K833647) received a 510(k) decision of Substantially Equivalent on December 16, 1983, 60 days after the submission was received.
What is the product code of K833647?
The FDA product code is KRE – Analyzer, Pacemaker Generator Function, Indirect, a Class II (moderate risk) device regulated under 21 CFR 870.3640.