510(k) K974899
K974899 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H". The FDA issued a decision of Substantially Equivalent on September 23, 1998. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Gambro Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1998
- Date Received
- December 30, 1997
- 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