510(k) K944493
K944493 is an FDA 510(k) premarket notification submitted by G.E.M. Water Systems for the device "REVERSE OSMOSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on February 20, 1996. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. G.E.M. Water Systems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1996
- Date Received
- September 13, 1994
- 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