The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Exonix.
| Device ID | K984199 |
| 510k Number | K984199 |
| Device Name: | EXONIX |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago, IL 60630 |
| Contact | Robert Brohm |
| Correspondent | Robert Brohm FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago, IL 60630 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-02-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EXONIX 75648453 2332052 Dead/Cancelled |
CAREFUSION 2200, INC. 1999-02-25 |