K Number
K962528Device Name
OLYMPUS MOBILE CHAIR/COUCHManufacturer
Date Cleared
1996-12-12
(168 days)
Product Code
Regulation Number
878.4950Type
TraditionalPanel
RAReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 878.4950 Manual operating table and accessories and manual operating chair and accessories.
(a)
Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.(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 § 878.9.