The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Sonos 100 Cf Ultrasound Imaging System.
Device ID | K922184 |
510k Number | K922184 |
Device Name: | HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | Pamela J Weagraff |
Correspondent | Pamela J Weagraff HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-11 |
Decision Date | 1992-07-30 |