The following data is part of a premarket notification filed by Midmark Corporation with the FDA for Midmark Extraoral Imaging System (eois).
| Device ID | K201667 |
| 510k Number | K201667 |
| Device Name: | Midmark Extraoral Imaging System (EOIS) |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Midmark Corporation 1001 Asbury Drive Buffalo Grove, IL 60089 |
| Contact | Mark Kenar |
| Correspondent | Mark Kenar Midmark Corporation 1001 Asbury Drive Buffalo Grove, IL 60089 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-19 |
| Decision Date | 2020-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709118401 | K201667 | 000 |
| 00841709118432 | K201667 | 000 |
| 00841709118340 | K201667 | 000 |
| 00841709118357 | K201667 | 000 |
| 00841709118364 | K201667 | 000 |
| 00841709118371 | K201667 | 000 |
| 00841709118388 | K201667 | 000 |
| 00841709118395 | K201667 | 000 |
| 00841709118449 | K201667 | 000 |
| 00841709118487 | K201667 | 000 |
| 00841709118494 | K201667 | 000 |
| 00841709118500 | K201667 | 000 |
| 00841709118418 | K201667 | 000 |
| 00841709118456 | K201667 | 000 |
| 00841709118463 | K201667 | 000 |
| 00841709118470 | K201667 | 000 |
| 00841709118425 | K201667 | 000 |