The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Sdu 800 Diagnostic Ultrasound Instrument.
Device ID | K890913 |
510k Number | K890913 |
Device Name: | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 101 W. WALNUT ST. Gardena, CA 90248 |
Contact | Hiroji Kanamori |
Correspondent | Hiroji Kanamori SHIMADZU PRECISION INSTRUMENTS, INC. 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 | 1989-02-24 |
Decision Date | 1989-09-06 |