CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES

• K Number: K003840
• Device Name: CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
• Manufacturer: I.C. MEDICAL, INC.
• Date Cleared: 2001-02-01 ( 51 days)
• Product Code: FYD
• Regulation Number: 878.5070

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

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Summary

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