510(k) K981085
K981085 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 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
- May 18, 1998
- Date Received
- March 25, 1998
- 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