CapMedic
Nebulizer (direct Patient Interface)
Cognita Labs, LLC
The following data is part of a premarket notification filed by Cognita Labs, Llc with the FDA for Capmedic.
Pre-market Notification Details
| Device ID | K183586 |
| 510k Number | K183586 |
| Device Name: | CapMedic |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana, CA 92701 |
| Contact | Rajoshi Biswas |
| Correspondent | Rajoshi Biswas Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana, CA 92701 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003953709 | K183586 | 000 |
Trademark Results [CapMedic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPMEDIC 86820667 5885618 Live/Registered |
Cognita Labs, LLC 2015-11-15 |
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