510(k) K131583
K131583 is an FDA 510(k) premarket notification submitted by Thermasolutions, Inc. for the device "THERMOCHEM HT-2000". The FDA issued a decision of Substantially Equivalent on October 3, 2013. The device falls under product code MLW (Warmer, Peritoneal Dialysate), a Class II device regulated under 21 CFR 876.5630. Thermasolutions, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2013
- Date Received
- May 31, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Peritoneal Dialysate
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type