The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Cag-02a.
Device ID | K922098 |
510k Number | K922098 |
Device Name: | CAG-02A |
Classification | Table, Radiologic |
Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
Contact | Timothy W Capehart |
Correspondent | Timothy W Capehart TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-06 |
Decision Date | 1992-07-27 |