510(k) K200670
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2020
- Date Received
- March 13, 2020
- Clearance Type
- Special
- 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