The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sd 800 Sonodiagnost Ultrasound Imaging System.
| Device ID | K970034 |
| 510k Number | K970034 |
| Device Name: | SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Paul Schrader |
| Correspondent | Paul Schrader HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-03 |
| Decision Date | 1997-03-17 |
| Summary: | summary |