The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Optiplanimat.
Device ID | K781531 |
510k Number | K781531 |
Device Name: | OPTIPLANIMAT |
Classification | System, X-ray, Tomographic |
Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IZF |
CFR Regulation Number | 892.1740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-06 |
Decision Date | 1978-09-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPTIPLANIMAT 73072872 1042801 Dead/Expired |
SIEMENS AKTIENGESELLSCHAFT 1975-12-29 |