510(k) K011243
K011243 is an FDA 510(k) premarket notification submitted by Chattanooga Group, Inc. for the device "CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000". The FDA issued a decision of Substantially Equivalent on July 6, 2001. The device falls under product code LSB (Unit, Fluidotherapy), a Class II device regulated under 21 CFR 890.5100. Chattanooga Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2001
- Date Received
- April 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Fluidotherapy
- Device Class
- Class II
- Regulation Number
- 890.5100
- Review Panel
- PM
- Submission Type