The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Sonos Ultrasound Imaging System.
Device ID | K954028 |
510k Number | K954028 |
Device Name: | HP SONOS 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 |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-28 |
Decision Date | 1996-08-08 |
Summary: | summary |