PulmoScan
Impedance Measuring Device Utilizing Oscillation Techniques
Cognita Labs, LLC
The following data is part of a premarket notification filed by Cognita Labs, Llc with the FDA for Pulmoscan.
Pre-market Notification Details
| Device ID | K191876 |
| 510k Number | K191876 |
| Device Name: | PulmoScan |
| Classification | Impedance Measuring Device Utilizing Oscillation Techniques |
| 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 | PNV |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2020-03-18 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003953716 | K191876 | 000 |
Trademark Results [PulmoScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PULMOSCAN 90114650 not registered Live/Pending |
Nemedis, Inc. 2020-08-14 |
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