510(k) K982829
K982829 is an FDA 510(k) premarket notification submitted by Chattanooga Group, Inc. for the device "FORTE, MODEL CPS ULTRASOUND". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Chattanooga Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1998
- Date Received
- August 11, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type