Broncholab
FDA 510(k) clearance K191550 · decided 2020-03-04
Clearance details
- K-number
- K191550
- Device name
- Broncholab
- Applicant
- Fluidda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-12
- Decision date
- 2020-03-04
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- West Hollywood, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.