The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Vantage Model V5000, V5100, V5000c, V5100c.
| Device ID | K122643 |
| 510k Number | K122643 |
| Device Name: | VANTAGE MODEL V5000, V5100, V5000C, V5100C |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | MIDMARK CORP. 675 HEATHROW DRIVE Lincolnshire, IL 60069 |
| Contact | Mark Greenwood |
| Correspondent | Mark Greenwood MIDMARK CORP. 675 HEATHROW DRIVE Lincolnshire, IL 60069 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2013-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709102592 | K122643 | 000 |
| 00841709102585 | K122643 | 000 |
| 00841709102578 | K122643 | 000 |
| 00841709102561 | K122643 | 000 |
| 00841709102554 | K122643 | 000 |
| 00841709102547 | K122643 | 000 |
| 00841709102530 | K122643 | 000 |