The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Shimadzu Lateral C-arm Mh-31.
Device ID | K882311 |
510k Number | K882311 |
Device Name: | SHIMADZU LATERAL C-ARM MH-31 |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
Contact | Hiroyuki Hattori,phd |
Correspondent | Hiroyuki Hattori,phd SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-03 |
Decision Date | 1988-09-14 |