The following data is part of a premarket notification filed by Sota Precision Optics, Inc. with the FDA for Clio/cliosoft.
Device ID | K110886 |
510k Number | K110886 |
Device Name: | CLIO/CLIOSOFT |
Classification | System, Image Processing, Radiological |
Applicant | SOTA PRECISION OPTICS, INC. 1073 NORTH BATAVIA ST. SUITE B Orange, CA 92867 |
Contact | Brian Kim |
Correspondent | Brian Kim SOTA PRECISION OPTICS, INC. 1073 NORTH BATAVIA ST. SUITE B Orange, CA 92867 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-30 |
Decision Date | 2011-06-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851159007026 | K110886 | 000 |
00851159007019 | K110886 | 000 |
00851159007002 | K110886 | 000 |