The following data is part of a premarket notification filed by Energy-lab Technologies Gmbh with the FDA for Vicardio 12b.
| Device ID | K082380 |
| 510k Number | K082380 |
| Device Name: | VICARDIO 12B |
| Classification | Electrocardiograph |
| Applicant | ENERGY-LAB TECHNOLOGIES GMBH 377 ROUTE 17 Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-19 |
| Decision Date | 2008-12-03 |
| Summary: | summary |