The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Intelect Legend Ultrasound.
Device ID | K973024 |
510k Number | K973024 |
Device Name: | INTELECT LEGEND ULTRASOUND |
Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
Contact | Joe Elrod |
Correspondent | Joe Elrod CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 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 | 1997-08-14 |
Decision Date | 1997-11-10 |