The following data is part of a premarket notification filed by Cygnus, Llc with the FDA for Cygnus 12 Lead Ecg Module.
| Device ID | K072950 |
| 510k Number | K072950 |
| Device Name: | CYGNUS 12 LEAD ECG MODULE |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | CYGNUS, LLC 510 EAST 41ST ST. Paterson, NJ 07504 |
| Contact | Narcis Naydenov |
| Correspondent | Narcis Naydenov CYGNUS, LLC 510 EAST 41ST ST. Paterson, NJ 07504 |
| Product Code | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-18 |
| Decision Date | 2008-08-22 |
| Summary: | summary |