510(k) K844484

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

K844484 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA". The FDA issued a decision of Substantially Equivalent on July 24, 1985. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Vitatron Medical BV has at least 10 other 510(k) clearances on record.

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