The following data is part of a premarket notification filed by 3nt Medical Ltd. with the FDA for Colibri Endoscopy System.
| Device ID | K192305 |
| 510k Number | K192305 |
| Device Name: | Colibri Endoscopy System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | 3NT Medical Ltd. 22 HaMelacha St., POB 11384 Rosh Ha’ayin, IL 4809169 |
| Contact | Ehud Bendory |
| Correspondent | Orly Maor Orly Maor 25A Sirkin Street Kfar Saba, IL 4442156 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016539097 | K192305 | 000 |
| 07290016539202 | K192305 | 000 |
| 17290016539223 | K192305 | 000 |