The following data is part of a premarket notification filed by Meta Biomed, Inc. with the FDA for Rextar, Rextar Lcd.
| Device ID | K122016 |
| 510k Number | K122016 |
| Device Name: | REXTAR, REXTAR LCD |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Contact | Blix Winston |
| Correspondent | Blix Winston META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-10 |
| Decision Date | 2013-03-01 |
| Summary: | summary |