The following data is part of a premarket notification filed by Shina Systems Ltd. with the FDA for Cardioct.
Device ID | K070226 |
510k Number | K070226 |
Device Name: | CARDIOCT |
Classification | System, Image Processing, Radiological |
Applicant | SHINA SYSTEMS LTD. POB 6718 Efrat, IL 90435 |
Contact | Eli M Orbach |
Correspondent | Eli M Orbach SHINA SYSTEMS LTD. POB 6718 Efrat, IL 90435 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-24 |
Decision Date | 2007-03-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARDIOCT 78254121 not registered Dead/Abandoned |
Shina syatem LTD 2003-05-24 |