The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Tosbee.
Device ID | K914583 |
510k Number | K914583 |
Device Name: | TOSBEE |
Classification | Generator, Low Voltage, Therapeutic X-ray |
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 | IYD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-16 |
Decision Date | 1993-01-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TOSBEE 74125357 1855647 Dead/Cancelled |
Kabushiki Kaisha Toshiba 1990-12-21 |