The following data is part of a premarket notification filed by Dexcowin Co., Ltd with the FDA for Adx4000w.
| Device ID | K134055 |
| 510k Number | K134055 |
| Device Name: | ADX4000W |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | DEXCOWIN CO., LTD 110 EAST GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin DEXCOWIN CO., LTD 110 EAST GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-05-09 |
| Summary: | summary |