The following data is part of a premarket notification filed by Codonics, Inc. with the FDA for Codonics Ep-1000 Medical Color Dry Imagers.
| Device ID | K030690 |
| 510k Number | K030690 |
| Device Name: | CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS |
| Classification | Camera, Multi Format, Radiological |
| Applicant | CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Contact | Rick Dayton |
| Correspondent | Rick Dayton CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-05 |
| Decision Date | 2003-04-30 |
| Summary: | summary |