The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Sdl 310 Diagnostic Ultrasound Instrument.
| Device ID | K896999 |
| 510k Number | K896999 |
| Device Name: | SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHIMADZU CORP. 101 W. WALNUT ST. Gardena, CA 90248 |
| Contact | Hiroji Kanamori |
| Correspondent | Hiroji Kanamori SHIMADZU CORP. 101 W. WALNUT ST. Gardena, CA 90248 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-08-09 |