510(k) K991519
K991519 is an FDA 510(k) premarket notification submitted by Ameriwater for the device "AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on April 14, 2000. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Ameriwater has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2000
- Date Received
- April 30, 1999
- 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