OTOPLAN
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Cascination AG
The following data is part of a premarket notification filed by Cascination Ag with the FDA for Otoplan.
Pre-market Notification Details
| Device ID | K220300 |
| 510k Number | K220300 |
| Device Name: | OTOPLAN |
| Classification | Image Management Software For Planning Of Otologic And Neurotologic Procedures |
| Applicant | Cascination AG Steigerhubelstrasse 3 Bern, CH 3008 |
| Contact | Jean-Francois Clemence |
| Correspondent | Jean-Francois Clemence Cascination AG Steigerhubelstrasse 3 Bern, CH 3008 |
| Product Code | QQE |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-02 |
| Decision Date | 2022-06-24 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167222414 | K220300 | 000 |
Trademark Results [OTOPLAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OTOPLAN 87644166 not registered Live/Pending |
CAScination AG 2017-10-13 |
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