510(k) K822820
K822820 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAS-FLOW METER GFL 10". The FDA issued a decision of Substantially Equivalent on October 18, 1982. The device falls under product code DTX (Gas Control Unit, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4300. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1982
- Date Received
- September 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas Control Unit, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4300
- Review Panel
- CV
- Submission Type