MIELE G 7781 DENTAL THERMAL DISINFECTOR

• K Number: K950518
• Device Name: MIELE G 7781 DENTAL THERMAL DISINFECTOR
• Manufacturer: MIELE PROFESSIONAL
• Date Cleared: 1996-01-26 ( 354 days)
• Product Code: LDS
• Regulation Number: 880.6991

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

§ 880.6991 Medical washer.

(a)
Identification. A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Summary

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