510(k) K782073

DINAMAP MODELS 1160 AND 1165 by Applied Medical Research — Product Code DSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1979
Date Received
December 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type