510(k) K822822
K822822 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO PRESSURE MONITOR PRM 10". The FDA issued a decision of Substantially Equivalent on October 18, 1982. The device falls under product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4310. 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
- Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4310
- Review Panel
- CV
- Submission Type