QT ECG— 510(k) K180157
Substantially EquivalentQT Medical, Inc.
FDA 510(k) clearance K180157 for QT ECG, Substantially Equivalent on 2018-05-04. Applicant: QT Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- QT Medical, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torrance, CA, US
Recent devices under product code DXH
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