RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER— 510(k) K063609
Substantially EquivalentShl Telemedicine International , Ltd.
FDA 510(k) clearance K063609 for RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER, Substantially Equivalent on 2007-09-12. Applicant: Shl Telemedicine International , Ltd.. Device class: 2.
Clearance details
- Applicant
- Shl Telemedicine International , Ltd.
- 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
- Somerset, MA, US
Recent devices under product code DXH
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