The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Scout 3.2/45 Mhz Coronary Imaging Catheter, Scout 3.2/45 Mhz Coronary Imaging Catheter, Scout Imaging Catheter Patient T.
| Device ID | K974457 |
| 510k Number | K974457 |
| Device Name: | SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Rob Butler |
| Correspondent | Rob Butler HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-07-14 |
| Summary: | summary |