The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Philips Ultrasound P800 Imaging System.
| Device ID | K935923 |
| 510k Number | K935923 |
| Device Name: | PHILIPS ULTRASOUND P800 IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Paul Schrader |
| Correspondent | Paul Schrader HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-12-08 |