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 |