The following data is part of a premarket notification filed by Jpi Healthcare Co, Ltd. with the FDA for Examvue Duo.
| Device ID | K213057 |
| 510k Number | K213057 |
| Device Name: | ExamVue Duo |
| Classification | System, X-ray, Stationary |
| Applicant | JPI Healthcare Co, Ltd. 608-Ho, 28, Digital-Ro 33-Gil, Guro-Gu Seoul, KR 08377 |
| Contact | Sam Kang |
| 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 | 2021-09-22 |
| Decision Date | 2022-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809413810679 | K213057 | 000 |