The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Reveal Intraoral Camera System.
| Device ID | K981937 |
| 510k Number | K981937 |
| Device Name: | WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | WELCH ALLYN, INC. 4619 JORDAN RD. Skaneateles Falls, NY 13153 -0187 |
| Contact | Kathy Lowther |
| Correspondent | Kathy Lowther WELCH ALLYN, INC. 4619 JORDAN RD. Skaneateles Falls, NY 13153 -0187 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-02 |
| Decision Date | 1998-08-24 |
| Summary: | summary |