The following data is part of a premarket notification filed by Vitatron Medical Bv with the FDA for Hewlett Packardt Hp 85 W/ Vitatron Ph1 Program Hea.
Device ID | K844484 |
510k Number | K844484 |
Device Name: | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA |
Classification | Programmer, Pacemaker |
Applicant | VITATRON MEDICAL BV P.O. BOX 76 6950 AB Dieren, NL |
Contact | Renirie |
Correspondent | Renirie VITATRON MEDICAL BV P.O. BOX 76 6950 AB Dieren, NL |
Product Code | KRG |
CFR Regulation Number | 870.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-19 |
Decision Date | 1985-07-24 |