The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Modification To Kodak Directview Cr 800/900 System.
| Device ID | K021829 |
| 510k Number | K021829 |
| Device Name: | MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Contact | Carol Ryerson |
| Correspondent | Carol Ryerson EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889971307125 | K021829 | 000 |