The following data is part of a premarket notification filed by Fair Image, Inc. with the FDA for Dexis Model 601 Dental Electronic Imaging System.
Device ID | K962631 |
510k Number | K962631 |
Device Name: | DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | FAIR IMAGE, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf FAIR IMAGE, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-05 |
Decision Date | 1996-11-26 |