The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Color Enhancement Function For The Ssa-380a.
| Device ID | K963705 |
| 510k Number | K963705 |
| Device Name: | COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Steven M Kay |
| Correspondent | Steven M Kay TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-12-02 |
| Summary: | summary |