510(k) K822071
K822071 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "PUMP MODULES PMO LO-110-PMD 10-210". The FDA issued a decision of Substantially Equivalent on August 24, 1982. The device falls under product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type), a Class II device regulated under 21 CFR 870.4370. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1982
- Date Received
- July 14, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4370
- Review Panel
- CV
- Submission Type