510(k) K152585
K152585 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "Resmon PRO FULL". The FDA issued a decision of Substantially Equivalent on June 24, 2016. The device falls under product code PNV (Impedance Measuring Device Utilizing Oscillation Techniques), a Class II device regulated under 21 CFR 868.1840. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2016
- Date Received
- September 10, 2015
- 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.