The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Bucky Stand Br-10m.
Device ID | K942792 |
510k Number | K942792 |
Device Name: | BUCKY STAND BR-10M |
Classification | System, X-ray, Stationary |
Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Michael Fishback |
Correspondent | Michael Fishback SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-14 |
Decision Date | 1994-07-29 |