510(k) K810127
K810127 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO BICARBONATE MODULE, BCM-10". The FDA issued a decision of Substantially Equivalent on February 25, 1981. The device falls under product code FKR (Subsystem, Proportioning), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1981
- Date Received
- January 19, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Subsystem, Proportioning
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type