CG-2211 SELFCHECK ECG TRANSMITTER— 510(k) K012223
Substantially EquivalentCard Guard Scientific Survival , Ltd.
FDA 510(k) clearance K012223 for CG-2211 SELFCHECK ECG TRANSMITTER, Substantially Equivalent on 2001-09-10. Applicant: Card Guard Scientific Survival , Ltd.. Device class: 2.
Clearance details
- Applicant
- Card Guard Scientific Survival , 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
- Rehovot, IL
Recent devices under product code DXH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.