The following data is part of a premarket notification filed by Jpi Healthcare Co., Ltd with the FDA for Exam Vue Dr.
| Device ID | K142930 |
| 510k Number | K142930 |
| Device Name: | Exam Vue DR |
| Classification | System, X-ray, Stationary |
| Applicant | JPI HEALTHCARE CO., LTD WOOLIM E-BIZ CENTER #608,170-5 Kuro 3-dong, Kuru-gu, KR 152-769 |
| Contact | Wonsik (stanley) Youn |
| Correspondent | William Little JPI Healthcare Solutions, Inc 52 Newtown Plaza Plainview, NY 11803 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-09 |
| Decision Date | 2015-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809413810488 | K142930 | 000 |