The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Bucky Table Bk-12.
Device ID | K920729 |
510k Number | K920729 |
Device Name: | BUCKY TABLE BK-12 |
Classification | Table, Radiographic, Stationary Top |
Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
Contact | De Mint |
Correspondent | De Mint SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-18 |
Decision Date | 1992-04-27 |