The following data is part of a premarket notification filed by Codonics, Inc. with the FDA for Codonics Horizon Ci Medical Multimedia Dry Imager; Codonics Horizon Gs Medical Multimedia Grey Scale Dry Imager.
| Device ID | K021054 |
| 510k Number | K021054 |
| Device Name: | CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER |
| 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 | 2002-04-01 |
| Decision Date | 2002-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814905020267 | K021054 | 000 |
| 00814905020069 | K021054 | 000 |
| 00814905020076 | K021054 | 000 |
| 00814905020083 | K021054 | 000 |
| 00814905020090 | K021054 | 000 |
| 00814905020106 | K021054 | 000 |
| 00814905020113 | K021054 | 000 |
| 00814905020151 | K021054 | 000 |
| 00814905020168 | K021054 | 000 |
| 00814905020175 | K021054 | 000 |
| 00814905020182 | K021054 | 000 |
| 00814905020199 | K021054 | 000 |
| 00814905020205 | K021054 | 000 |
| 00814905020212 | K021054 | 000 |
| 00814905020052 | K021054 | 000 |