TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM

• K Number: K963505
• Device Name: TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
• Manufacturer: TENET MEDICAL ENGINEERING
• Date Cleared: 1997-02-14 ( 164 days)
• Product Code: HHP
• Regulation Number: 884.4900

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

§ 884.4900 Obstetric table and accessories.

(a)
Identification. An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Summary

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