The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sonos 5500 Imaging System.
| Device ID | K971116 |
| 510k Number | K971116 |
| Device Name: | SONOS 5500 IMAGING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1087 |
| Contact | Paul Schrader |
| Correspondent | Paul Schrader HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1087 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-26 |
| Decision Date | 1998-01-12 |
| Summary: | summary |