MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE— 510(k) K904745
Substantially EquivalentGraphic Controls Corp.
FDA 510(k) clearance K904745 for MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE, Substantially Equivalent on 1991-01-29. Applicant: Graphic Controls Corp.. Device class: 2.
Clearance details
- Applicant
- Graphic Controls Corp.
- Product code
- Code HGP
- Device class
- Class 2
- Regulation
- 21 CFR 884.2675
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.