510(k) K072158
K072158 is an FDA 510(k) premarket notification submitted by Staubach Barror Water Systems, Inc. for the device "AQUA PURE DEIONIZER EXCHANGE SERVICE". The FDA issued a decision of Substantially Equivalent on Feb 21, 2008. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 2008
- Date Received
- Aug 3, 2007
- 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
- 510(k)