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CapMedic®
Cognita Labs, LLC · Model CAPMED-C · UDI-DI 00860003953709
BZK
Prescription
10
510(k) clearances
136
Adverse events (2 deaths)
3
Recalls
38
Facilities
Description
CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-01 | Mindray DS USA, Inc. dba Mindray North America | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. |
| 2011-07-29 | Respironics Novametrix, LLC. | Pressure lines maybe occluded and display incorrect tidal volumes. |
| 2011-07-29 | Respironics Novametrix, LLC. | Pressure lines maybe occluded and display incorrect tidal volumes. |
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