The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett Packard Multi Function Adult Defib Electrode, Model M3501a & M3502a.
Device ID | K991871 |
510k Number | K991871 |
Device Name: | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | HEWLETT-PACKARD CO. 2500 BELL AVE. Des Moines, IA 50321 |
Contact | Warren R Walters |
Correspondent | Warren R Walters HEWLETT-PACKARD CO. 2500 BELL AVE. Des Moines, IA 50321 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-01 |
Decision Date | 1999-08-05 |