The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Kodak 1500 Intraoral Camera.
| Device ID | K091186 |
| 510k Number | K091186 |
| Device Name: | KODAK 1500 INTRAORAL CAMERA |
| Classification | Unit, Operative Dental |
| Applicant | CARESTREAM HEALTH, INC. 1765 THE EXCHANGE Atlanta, GA 30339 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer CARESTREAM HEALTH, INC. 1765 THE EXCHANGE Atlanta, GA 30339 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192156559852 | K091186 | 000 |
| 60192156559814 | K091186 | 000 |
| 60192156559807 | K091186 | 000 |