Broncholab
System, X-ray, Tomography, Computed
Fluidda Inc.
The following data is part of a premarket notification filed by Fluidda Inc. with the FDA for Broncholab.
Pre-market Notification Details
| Device ID | K191550 |
| 510k Number | K191550 |
| Device Name: | Broncholab |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Fluidda Inc. 750 N. San Vicente Blvd, Suite 800 West West Hollywood, CA 90069 |
| Contact | Anjali Nair |
| Correspondent | Anjali Nair Fluidda Inc. 750 N. San Vicente Blvd, Suite 800 West West Hollywood, CA 90069 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2020-03-04 |
Trademark Results [Broncholab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRONCHOLAB 79218857 5499967 Live/Registered |
Fluidda, naamloze vennootschap 2017-02-03 |
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