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 |