The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Modified Syst: Sonos 500/1000 Ultrsound Imag Syst.
Device ID | K904832 |
510k Number | K904832 |
Device Name: | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST |
Classification | Echocardiograph |
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 | DXK |
CFR Regulation Number | 870.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-23 |
Decision Date | 1991-04-22 |