The following data is part of a premarket notification filed by Endo Optiks, Inc. with the FDA for Transtympanic Endoscope.
| Device ID | K945081 |
| 510k Number | K945081 |
| Device Name: | TRANSTYMPANIC ENDOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
| Contact | Jim Ohneck |
| Correspondent | Jim Ohneck ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-17 |
| Decision Date | 1995-03-06 |