The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Sdl-32 Electronic Linear Scanner.
Device ID | K850834 |
510k Number | K850834 |
Device Name: | SDL-32 ELECTRONIC LINEAR SCANNER |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | SHIMADZU CORP. 16921 S WESTERN AVE #102 Gardena, CA 90247 |
Contact | Takao Someyama |
Correspondent | Takao Someyama SHIMADZU CORP. 16921 S WESTERN AVE #102 Gardena, CA 90247 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-01 |
Decision Date | 1985-10-31 |