510(k) K063609— RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
Substantially EquivalentShl Telemedicine International , Ltd.
Clearance details
- Applicant
- Shl Telemedicine International , Ltd.
- Product code
- Code DXH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.