PulmoScan
FDA 510(k) K191876 · Cognita Labs, LLC
510(k) numberK191876
Submission
- Device name
- PulmoScan
- Applicant
- Cognita Labs, LLC
Santa Ana, CA, US - Received
- July 15, 2019
- Decision date
- March 18, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K170185 | tremoFlo C-100 Airwave Oscillometry SystemPNV · Traditional | Thorasys Thoracic Medical Systems, Inc. | 09/12/2017SE |
| K152585 | Resmon PRO FULLPNV · Traditional | Medical Graphics Corp. | 06/24/2016SE |
More from Medical Graphics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K183586 | CapMedicCAF · Traditional | 09/13/2019SE |
Questions and answers
When was PulmoScan cleared by the FDA?
PulmoScan (K191876) received a 510(k) decision of Substantially Equivalent on March 18, 2020, 247 days after the submission was received.
What is the product code of K191876?
The FDA product code is PNV – Impedance Measuring Device Utilizing Oscillation Techniques, a Class II (moderate risk) device regulated under 21 CFR 868.1840.