Resmon PRO FULL
FDA 510(k) clearance K152585 · decided 2016-06-24
Clearance details
- K-number
- K152585
- Device name
- Resmon PRO FULL
- Applicant
- Medical Graphics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-10
- Decision date
- 2016-06-24
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- PNV
- Device class
- 2
- Regulation number
- 868.1840
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| tremoflo C2 Airwave Oscillometry System (K221024) | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 |
| PulmoScan (K191876) | Cognita Labs, LLC | 2020-03-18 |
| tremoFlo C-100 Airwave Oscillometry System (K170185) | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 |
Recalls involving this device
No recalls on record reference this clearance.