The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Infimed Dental System.
| Device ID | K962422 |
| 510k Number | K962422 |
| Device Name: | INFIMED DENTAL SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Morteza Minaee |
| Correspondent | Morteza Minaee INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1997-09-11 |