The following data is part of a premarket notification filed by Cybermed, Inc. with the FDA for Ondemand3d.
Device ID | K070464 |
510k Number | K070464 |
Device Name: | ONDEMAND3D |
Classification | System, Image Processing, Radiological |
Applicant | CYBERMED, INC. #504 SJ TECHNOVILLE, GASAN-DONG 60-19, GEUMCHEON-GU Seoul, KR 153-710 |
Contact | Song N Choi |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-02-16 |
Decision Date | 2007-03-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
88000231000068 | K070464 | 000 |
08800023100068 | K070464 | 000 |
08800023100006 | K070464 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ONDEMAND3D 78913546 not registered Dead/Abandoned |
CYBERMED, INC. 2006-06-21 |