The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model 7700a/77010a/77025a/77030a/77035a Ultra Imag.
| Device ID | K913827 |
| 510k Number | K913827 |
| Device Name: | MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG |
| Classification | Flowmeter, Blood, Cardiovascular |
| 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 | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1991-11-19 |