The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Modified Software To The Sonos 100 Ultrasound.
Device ID | K902088 |
510k Number | K902088 |
Device Name: | MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | V Anderson |
Correspondent | V Anderson HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-10 |
Decision Date | 1990-08-08 |