The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Applied Medical Anoscope.
| Device ID | K200021 |
| 510k Number | K200021 |
| Device Name: | Applied Medical Anoscope |
| Classification | Anoscope And Accessories |
| Applicant | Applied Medical Resources 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Frans Vandenbroek |
| Correspondent | Aeree Lee Applied Medical Resources 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-06 |
| Decision Date | 2021-01-06 |