510(k) K191876
- Device
- PulmoScan
- Applicant
- Cognita Labs, LLC
- 510(k) number
- K191876
- Product code
- PNV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-18
- Date received
- 2019-07-15
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rajoshi Biswas
- Address
- 700 N Main St. Suite C1 Santa Ana CA US 92701 92701
FDA Registration Numbers#
- 3011331794
- 3012624216
- 3017200972
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K170185 | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 |
| K152585 | Resmon PRO FULL | Medical Graphics Corp. | 2016-06-24 |
Legacy Summary#
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FDA Review#
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