The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Video Otoscope.
| Device ID | K943731 |
| 510k Number | K943731 |
| Device Name: | VIDEO OTOSCOPE |
| Classification | Otoscope |
| Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Joseph Cuda |
| Correspondent | Joseph Cuda CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-10-11 |