510(k) K072950
- Device
- CYGNUS 12 LEAD ECG MODULE
- Applicant
- CYGNUS, LLC
- 510(k) number
- K072950
- Product code
- KRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-08-22
- Date received
- 2007-10-18
- Regulation
- 870.3640
- Classification name
- Analyzer, Pacemaker Generator Function, Indirect
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NARCIS NAYDENOV
- Address
- 510 E. 41st St. Paterson NJ US 07504 07504
FDA Registration Numbers#
- 2182208
- 3018094310
Source Documents#
Other 510(k) Records For Product Code KRE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110693 | PACEART OPTIMA SYSTEM SOFTWARE | Medtronic, Inc. | 2011-06-08 |
| K032926 | EKG SPEAKS | Medtronic Vascular | 2003-10-15 |
| K922742 | HPM 40 HEART PACEMAKER MONITOR | Biotronik, GmbH & Co. | 1993-03-18 |
| K915632 | PACEART CPTS-86/12 | Paceart, Inc. | 1992-04-14 |
| K895535 | PACEVIEW | Micromedical | 1990-03-19 |
| K870909 | PACEMAKER FUNCTION ANALYZER | Paceart, Inc. | 1987-04-27 |
| K833647 | PACEMAKER SYS ANALYZER #384 | Pacesetter Systems | 1983-12-16 |
| K832959 | PACEMAKER SYS. ANALYZER 378 | Siemens Elema AB | 1983-11-14 |
| K803286 | CARDIOMEMO | Instromedix, Inc. | 1981-03-17 |
| K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | Instromedix, Inc. | 1980-08-14 |
| K801022 | ULTRA-CHEK PACEMAKER MONITOR | Powers Medical Systmes | 1980-06-17 |
| K800782 | PACE-PULSE/COMPUTRAC | Bib, Inc. | 1980-05-28 |
Legacy Summary#
summary
FDA Review#
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