The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett Packard Model 5650c, Cardio Data Mgmt Syst.
| Device ID | K905100 |
| 510k Number | K905100 |
| Device Name: | HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Contact | William C Kole |
| Correspondent | William C Kole HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1991-01-15 |