US SENSOR #CG-930P; TOCO SENSOR CG-940P— 510(k) K003876
Substantially EquivalentCard Guard Scientific Survival , Ltd.
FDA 510(k) clearance K003876 for US SENSOR #CG-930P; TOCO SENSOR CG-940P, Substantially Equivalent on 2001-07-09. Applicant: Card Guard Scientific Survival , Ltd.. Device class: 2.
Clearance details
- Applicant
- Card Guard Scientific Survival , Ltd.
- Product code
- Code HEL
- Device class
- Class 2
- Regulation
- 21 CFR 884.2660
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
Recent devices under product code HEL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.