K Number
K960027Device Name
HIGH VOLUME I.V. & IRRIGATION TOWERManufacturer
Date Cleared
1996-03-12
(70 days)
Product Code
Regulation Number
880.6990Type
TraditionalPanel
HOReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 880.6990 Infusion stand.
(a)
Identification. The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.