Otoplan
System, Image Processing, Radiological
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 | K203486 |
| 510k Number | K203486 |
| Device Name: | Otoplan |
| Classification | System, Image Processing, Radiological |
| Applicant | CAScination AG Steigerhubelstrasse 3 Bern, CH Ch-3008 |
| Contact | Jean-francois Clemence |
| Correspondent | Jean-francois Clemence CAScination AG Steigerhubelstrasse 3 Bern, CH Ch-3008 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-08-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167220724 | K203486 | 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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