510(k) K860076
K860076 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200". The FDA issued a decision of Substantially Equivalent on May 30, 1986. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1986
- Date Received
- January 8, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4340
- Review Panel
- CV
- Submission Type