510(k) K844484

HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA by Vitatron Medical BV — Product Code KRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1985
Date Received
November 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type