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FDA 510(k), K003458, SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
FDA 510(k), K003458, SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
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510(K) Number: K003458
Device Name: SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
Manufacturer: CLINICAL INNOVATIONS, INC.
Device Classification Name: Electrode, Circular (Spiral), Scalp And Applicator
Regulation Number: 884.2675
Classification Product Code: HGP
Date Received: 11/07/2000
Decision Date: 05/03/2001
Regulation Medical Specialty: Obstetrics/Gynecology
Total Pages: 221
Fully Redacted Pages: 136
Content Pages: 85
Device Name: SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
Manufacturer: CLINICAL INNOVATIONS, INC.
Device Classification Name: Electrode, Circular (Spiral), Scalp And Applicator
Regulation Number: 884.2675
Classification Product Code: HGP
Date Received: 11/07/2000
Decision Date: 05/03/2001
Regulation Medical Specialty: Obstetrics/Gynecology
Total Pages: 221
Fully Redacted Pages: 136
Content Pages: 85
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