The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Sdu-700 Phased Array Sector And Linear Scanner.
Device ID | K873674 |
510k Number | K873674 |
Device Name: | SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER |
Classification | Transducer, Ultrasonic |
Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
Contact | Takao Someyama |
Correspondent | Takao Someyama SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
Product Code | JOP |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-11 |
Decision Date | 1988-10-07 |