CARDIOLINE touchECG— 510(k) K160746
Substantially EquivalentCardioline S.P.A
FDA 510(k) clearance K160746 for CARDIOLINE touchECG, Substantially Equivalent on 2016-11-02. Applicant: Cardioline S.P.A. Device class: 2.
Clearance details
- Applicant
- Cardioline S.P.A
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Z.I. Spini Di Gardolo, IT
Recent devices under product code DPS
view allMore clearances from Cardioline S.P.A
view allAdverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.