The following data is part of a premarket notification filed by Vicor Technologies, Inc. with the FDA for Vicor Pd2i Analyzer, Version 2.1.
| Device ID | K082709 |
| 510k Number | K082709 |
| Device Name: | VICOR PD2I ANALYZER, VERSION 2.1 |
| Classification | Electrocardiograph |
| Applicant | VICOR TECHNOLOGIES, INC. 261 MADISON AVE. 24TH FLOOR New York, NY 10016 |
| Contact | Jules Mitchel |
| Correspondent | Jules Mitchel VICOR TECHNOLOGIES, INC. 261 MADISON AVE. 24TH FLOOR New York, NY 10016 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-16 |
| Decision Date | 2008-12-29 |
| Summary: | summary |