The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sonos 500, 1000, 1500/sonos Or Ultrasound Imag Sys.
Device ID | K921863 |
510k Number | K921863 |
Device Name: | SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS |
Classification | Echoencephalograph |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | Charles R Burr |
Correspondent | Charles R Burr HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | GXW |
CFR Regulation Number | 882.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-17 |
Decision Date | 1992-09-28 |