PulmoScan
FDA 510(k) clearance K191876 · decided 2020-03-18
Clearance details
- K-number
- K191876
- Device name
- PulmoScan
- Applicant
- Cognita Labs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-07-15
- Decision date
- 2020-03-18
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- PNV
- Device class
- 2
- Regulation number
- 868.1840
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| tremoflo C2 Airwave Oscillometry System (K221024) | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 |
| tremoFlo C-100 Airwave Oscillometry System (K170185) | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 |
| Resmon PRO FULL (K152585) | Medical Graphics Corp. | 2016-06-24 |
Recalls involving this device
No recalls on record reference this clearance.