The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Vectra (intelect) Epr Ultrasound.
| Device ID | K031116 |
| 510k Number | K031116 |
| Device Name: | VECTRA (INTELECT) EPR ULTRASOUND |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | CHATTANOOGA GROUP 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 |
| Contact | Mick Davis |
| Correspondent | Mick Davis CHATTANOOGA GROUP 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-08 |
| Decision Date | 2003-12-03 |