The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sonos 2000, Sonos 2500 (m2406 A).
Device ID | K964309 |
510k Number | K964309 |
Device Name: | SONOS 2000, SONOS 2500 (M2406 A) |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Paul Schrader |
Correspondent | Paul Schrader HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-29 |
Decision Date | 1997-04-22 |
Summary: | summary |