Resmon PRO FULL
FDA 510(k) K152585 · Medical Graphics Corp.
510(k) numberK152585
Submission
- Device name
- Resmon PRO FULL
- Applicant
- Medical Graphics Corp.
St. Paul, MN, US - Received
- September 10, 2015
- Decision date
- June 24, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNV – Impedance Measuring Device Utilizing Oscillation Techniques
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
This device measures respiratory impedance.
Other 510(k)s with product code PNV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221024 | tremoflo C2 Airwave Oscillometry SystemPNV · Traditional | Thorasys Thoracic Medical Systems, Inc. | 06/20/2023SE |
| K191876 | PulmoScanPNV · Traditional | Cognita Labs, LLC | 03/18/2020SE |
| K170185 | tremoFlo C-100 Airwave Oscillometry SystemPNV · Traditional | Thorasys Thoracic Medical Systems, Inc. | 09/12/2017SE |
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Questions and answers
When was Resmon PRO FULL cleared by the FDA?
Resmon PRO FULL (K152585) received a 510(k) decision of Substantially Equivalent on June 24, 2016, 288 days after the submission was received.
What is the product code of K152585?
The FDA product code is PNV – Impedance Measuring Device Utilizing Oscillation Techniques, a Class II (moderate risk) device regulated under 21 CFR 868.1840.