The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sonos 5500 Imaging System M2424a Version B.o.
Device ID | K990339 |
510k Number | K990339 |
Device Name: | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Ann Fay Michaels |
Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1999-02-03 |
Decision Date | 1999-02-18 |
Summary: | summary |