The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sonos 500 And Sonos 1000 Ultrasound Imaging System.
| Device ID | K905728 |
| 510k Number | K905728 |
| Device Name: | SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Charles R Burr |
| Correspondent | Charles R Burr HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-03-15 |