510(k) clearance
QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
- 510(k) number
- K260250
- Applicant
- QT Medical, Inc.
- Decision date
- Sep 29, 2026
- Date received
- Jan 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DPS
- Device type
- Electrocardiograph
- Device class
- Class II
- Regulation
- 21 CFR 870.2340
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Diamond Bar, CA, US