The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Sonos 100cf Ultrasound Imaging System.
| Device ID | K955327 |
| 510k Number | K955327 |
| Device Name: | HP SONOS 100CF ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Rob Butler |
| Correspondent | Rob Butler HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-20 |
| Decision Date | 1996-04-08 |
| Summary: | summary |