The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Portable X-ray System (model:exaro,xray2go).
Device ID | K141497 |
510k Number | K141497 |
Device Name: | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
Contact | Patrick Lim |
Correspondent | Patrick Lim OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-06 |
Decision Date | 2014-08-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858475006009 | K141497 | 000 |