510(k) K955808
K955808 is an FDA 510(k) premarket notification submitted by Thermia, Inc. for the device "DYNA T-2000 PHYSICAL THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 3, 1997. The device falls under product code IMB (Cabinet, Moist Steam), a Class II device regulated under 21 CFR 890.5250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1997
- Date Received
- December 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, Moist Steam
- Device Class
- Class II
- Regulation Number
- 890.5250
- Review Panel
- PM
- Submission Type