The following data is part of a premarket notification filed by Medimaging Integrated Solution Inc. (miis) with the FDA for Ent Nasopharyngoscope And Accessories.
| Device ID | K214050 |
| 510k Number | K214050 |
| Device Name: | ENT Nasopharyngoscope And Accessories |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Medimaging Integrated Solution Inc. (MiiS) 3F., No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, TW 30077 |
| Contact | Jung-Yi Yen |
| Correspondent | Jung-Yi Yen Medimaging Integrated Solution Inc. (MiiS) 3F., No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, TW 30077 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-07-01 |