The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sonos 5500 Ultrasound Imaging System.
Device ID | K980687 |
510k Number | K980687 |
Device Name: | SONOS 5500 ULTRASOUND IMAGING SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | Paul Schrader |
Correspondent | Paul Schrader HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | IYO |
Subsequent Product Code | ITX |
Subsequent Product Code | IYN |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-23 |
Decision Date | 1998-05-22 |
Summary: | summary |