510(k) K170185
K170185 is an FDA 510(k) premarket notification submitted by Thorasys Thoracic Medical Systems, Inc. for the device "tremoFlo C-100 Airwave Oscillometry System". The FDA issued a decision of Substantially Equivalent on September 12, 2017. The device falls under product code PNV (Impedance Measuring Device Utilizing Oscillation Techniques), a Class II device regulated under 21 CFR 868.1840. Thorasys Thoracic Medical Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2017
- Date Received
- January 23, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Impedance Measuring Device Utilizing Oscillation Techniques
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type
This device measures respiratory impedance.