SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000

• K Number: K003458
• Device Name: SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
• Manufacturer: CLINICAL INNOVATIONS, INC.
• Date Cleared: 2001-05-03 ( 177 days)
• Product Code: HGP
• Regulation Number: 884.2675

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 884.2675 Fetal scalp circular (spiral) electrode and applicator.

(a)
Identification. A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.(b)
Classification. Class II (performance standards).

Summary

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