510(k) K960916

SAMS 8000 CARDIOPLEGIA MONITOR by 3M Health Care, Sarns — Product Code DSJ

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