510(k) K152585
- Device
- Resmon PRO FULL
- Applicant
- MEDICAL GRAPHICS CORP.
- 510(k) number
- K152585
- Product code
- PNV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-24
- Date received
- 2015-09-10
- Regulation
- 868.1840
- Classification name
- Impedance Measuring Device Utilizing Oscillation Techniques
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JIM PURDIE
- Address
- 350 Oak Grove Pkwy. St. Paul MN US 55127 55127
FDA Registration Numbers#
- 3011331794
- 3012624216
- 3017200972
Source Documents#
Other 510(k) Records For Product Code PNV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221024 | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 |
| K191876 | PulmoScan | Cognita Labs, LLC | 2020-03-18 |
| K170185 | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 |
Legacy Summary#
summary
FDA Review#
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