SELFCHECK GLUCO— 510(k) K061528
Substantially EquivalentCard Guard Scientific Survival , Ltd.
FDA 510(k) clearance K061528 for SELFCHECK GLUCO, Substantially Equivalent on 2006-09-22. Applicant: Card Guard Scientific Survival , Ltd.. Device class: 2.
Clearance details
- Applicant
- Card Guard Scientific Survival , Ltd.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
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- K083174 — HEALTHEPOD
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
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.