Operio
Air Filter Portable Apparatus
TOUL MEDITECH AB
The following data is part of a premarket notification filed by Toul Meditech Ab with the FDA for Operio.
Pre-market Notification Details
| Device ID | K153498 |
| 510k Number | K153498 |
| Device Name: | Operio |
| Classification | Air Filter Portable Apparatus |
| Applicant | TOUL MEDITECH AB TUNBYTORPSGATAN 31 Västerås, SE 72137 |
| Contact | Tomas Hansson |
| Correspondent | Tomas Hansson TOUL MEDITECH AB TUNBYTORPSGATAN 31 Västerås, SE 72137 |
| Product Code | ORC |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-07-20 |
| Summary: | summary |
Trademark Results [Operio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPERIO 79164446 4920143 Live/Registered |
Toul Meditech AB 2015-03-12 |
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