The following data is part of a premarket notification filed by Intelwave, Llc with the FDA for Intelwave Heart Rate Variability System, Version 1.0.
| Device ID | K062068 |
| 510k Number | K062068 |
| Device Name: | INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 |
| Classification | Electrocardiograph |
| Applicant | INTELWAVE, LLC 1090 KING GEORGES POST ROAD SUITE 1004 Edison, NJ 08837 |
| Contact | Alexander Riftine |
| Correspondent | Alexander Riftine INTELWAVE, LLC 1090 KING GEORGES POST ROAD SUITE 1004 Edison, NJ 08837 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-21 |
| Decision Date | 2006-10-27 |
| Summary: | summary |