The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model 43100a Series Defibrillator, Modification.
| Device ID | K910754 |
| 510k Number | K910754 |
| Device Name: | MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-11 |
| Decision Date | 1991-05-08 |