The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Transesophageal Transducer Thermal Safety.
| Device ID | K912404 |
| 510k Number | K912404 |
| Device Name: | TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Leslie Fullerton |
| Correspondent | Leslie Fullerton HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-30 |
| Decision Date | 1991-11-07 |