The following data is part of a premarket notification filed by Cardiac Designs, Llc with the FDA for Enterprise Ecg Analysis / Interpretation Software.
| Device ID | K131045 |
| 510k Number | K131045 |
| Device Name: | ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CARDIAC DESIGNS, LLC 57 LAZY BROOK RD Monroe, CT 06468 |
| Contact | Raymond J Kelly, Iv |
| Correspondent | Raymond J Kelly, Iv CARDIAC DESIGNS, LLC 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-15 |
| Decision Date | 2013-05-29 |