The following data is part of a premarket notification filed by Optim, Llc with the FDA for Entity Wifi Video Nasopharyngoscope System.
| Device ID | K200609 |
| 510k Number | K200609 |
| Device Name: | ENTity WiFi Video Nasopharyngoscope System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Optim, LLC 64 Technology Park Rd. Sturbridge, MA 01566 |
| Contact | Jenna Lipka |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-09 |
| Decision Date | 2021-01-13 |