tremoFlo C-100 Airwave Oscillometry System
FDA 510(k) clearance K170185 · decided 2017-09-12
Clearance details
- K-number
- K170185
- Device name
- tremoFlo C-100 Airwave Oscillometry System
- Applicant
- Thorasys Thoracic Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-23
- Decision date
- 2017-09-12
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- PNV
- Device class
- 2
- Regulation number
- 868.1840
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| tremoflo C2 Airwave Oscillometry System (K221024) | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 |
| PulmoScan (K191876) | Cognita Labs, LLC | 2020-03-18 |
| Resmon PRO FULL (K152585) | Medical Graphics Corp. | 2016-06-24 |
Recalls involving this device
No recalls on record reference this clearance.