Pace-Pulse/Computrac
FDA 510(k) K800782 · Bib, Inc.
510(k) numberK800782
Submission
- Device name
- Pace-Pulse/Computrac
- Applicant
- Bib, Inc.
Mchenry, IL, US - Received
- April 8, 1980
- Decision date
- May 28, 1980
- 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 |
| K803286 | CardiomemoKRE · Traditional | Instromedix, Inc. | 03/17/1981SE |
More from Instromedix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830916 | Vita/Trac 4 Function Vital Sign MonitorDRT · Traditional | 07/07/1983SE |
| K801389 | Baro/Trac II & Vita/Trac, Vital Sign MonDXN · Traditional | 07/28/1980SE |
| K801366 | Disposable Temperature Probe CoverFLL · Traditional | 07/28/1980SE |
| K800596 | Vita/Trac 4-FUNCTION Vital Sign MonitorDXN · Traditional | 07/21/1980SE |
Questions and answers
When was Pace-Pulse/Computrac cleared by the FDA?
Pace-Pulse/Computrac (K800782) received a 510(k) decision of Substantially Equivalent on May 28, 1980, 50 days after the submission was received.
What is the product code of K800782?
The FDA product code is KRE – Analyzer, Pacemaker Generator Function, Indirect, a Class II (moderate risk) device regulated under 21 CFR 870.3640.