510(k) K940601
K940601 is an FDA 510(k) premarket notification submitted by C.G.H. Medical, Inc. for the device "GAMBRO BICART 720G". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. C.G.H. Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1994
- Date Received
- February 10, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type