FDA 510(k) Applications for Medical Device Product Code "HGP"
(Electrode, Circular (Spiral), Scalp And Applicator)

FDA 510(k) Number Applicant Device Name Decision Date
K030691 CLINICAL INNOVATIONS, INC. FETAL SPIRAL ELECTRODE, MODEL FSE07000 09/17/2003
K003458 CLINICAL INNOVATIONS, INC. SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 05/03/2001
K243291 Neoventa Medical AB Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) 01/17/2025


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact