The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sonos 100 Ultrasound Imaging System.
| Device ID | K921036 |
| 510k Number | K921036 |
| Device Name: | SONOS 100 ULTRASOUND IMAGING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Pamela J Wearaff |
| Correspondent | Pamela J Wearaff HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-04 |
| Decision Date | 1992-05-29 |