510(k) K121022
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2012
- Date Received
- April 4, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Subsystem, Water Purification
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type