CapMedic
510(k) K183586
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183586 | Date13 Sep 2019 | StatusActive |
Official records
- FDA 510(k) database K183586
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAF
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
CapMedic is a device designed to provide real-time audio-visual interactive guidance on correct inhaler use. It is a prescription-only device that helps users with proper inhaler technique.
CapMedic is supplied by Cognita Labs, LLC and has FDA 510K clearance with product code CAF. The device is intended to simplify respiratory care by enabling regular and correct inhaler use, though it does not replace the inhaler's packaged instructions.
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