510(k) K960916
K960916 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "SAMS 8000 CARDIOPLEGIA MONITOR". The FDA issued a decision of Substantially Equivalent on June 4, 1996. The device falls under product code DSJ (Alarm, Blood-Pressure), a Class II device regulated under 21 CFR 870.1100. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1996
- Date Received
- March 6, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alarm, Blood-Pressure
- Device Class
- Class II
- Regulation Number
- 870.1100
- Review Panel
- CV
- Submission Type