The following data is part of a premarket notification filed by Ecleris Usa with the FDA for Ecleris Sinuscope.
| Device ID | K131323 |
| 510k Number | K131323 |
| Device Name: | ECLERIS SINUSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Ecleris USA 57 LAZY BROOK RD Monroe, CT 06468 |
| Contact | Raymond J Kelly, Iv |
| Correspondent | Raymond J Kelly, Iv Ecleris USA 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-08 |
| Decision Date | 2014-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B366SN0470175R000 | K131323 | 000 |
| B366SN0330140 | K131323 | 000 |
| B366SN0370140 | K131323 | 000 |
| B366SN0400175 | K131323 | 000 |
| B366SN0430175 | K131323 | 000 |
| B366SN0445175 | K131323 | 000 |
| B366SN0470175 | K131323 | 000 |
| B366SN0300140R000 | K131323 | 000 |
| B366SN0330140R000 | K131323 | 000 |
| B366SN0370140R000 | K131323 | 000 |
| B366SN0400175R000 | K131323 | 000 |
| B366SN0430175R000 | K131323 | 000 |
| B366SN0445175R000 | K131323 | 000 |
| B366SN0300140 | K131323 | 000 |