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FDA 510(k), K030691, FETAL SPIRAL ELECTRODE, MODEL FSE07000
FDA 510(k), K030691, FETAL SPIRAL ELECTRODE, MODEL FSE07000
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510(K) Number: K030691
Device Name: FETAL SPIRAL ELECTRODE, MODEL FSE07000
Manufacturer: CLINICAL INNOVATIONS, INC.
Device Classification Name: Electrode, Circular (Spiral), Scalp And Applicator
Regulation Number: 884.2675
Classification Product Code: HGP
Date Received: 03/05/2003
Decision Date: 09/17/2003
Regulation Medical Specialty: Obstetrics/Gynecology
Total Pages: 93
Fully Redacted Pages: 34
Content Pages: 59
Device Name: FETAL SPIRAL ELECTRODE, MODEL FSE07000
Manufacturer: CLINICAL INNOVATIONS, INC.
Device Classification Name: Electrode, Circular (Spiral), Scalp And Applicator
Regulation Number: 884.2675
Classification Product Code: HGP
Date Received: 03/05/2003
Decision Date: 09/17/2003
Regulation Medical Specialty: Obstetrics/Gynecology
Total Pages: 93
Fully Redacted Pages: 34
Content Pages: 59
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