K152585 is an FDA 510(k) clearance for the Resmon PRO FULL. This device is classified as a Impedance Measuring Device Utilizing Oscillation Techniques (Class II - Special Controls, product code PNV).
Submitted by Medical Graphics Corp. (Saint Paul, US). The FDA issued a Cleared decision on June 24, 2016, 288 days after receiving the submission on September 10, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840. This Device Measures Respiratory Impedance..
| 510(k) Number | K152585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2015 |
| Decision Date | June 24, 2016 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | PNV — Impedance Measuring Device Utilizing Oscillation Techniques |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |
| Definition | This Device Measures Respiratory Impedance. |