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K Number
K945301

Validate with FDA (Live)

Device Name
LARYNGOSCOPE COVER
Manufacturer
SOTIRIA MOURKIDOU, M.D.
Date Cleared
1996-05-31

(578 days)

Product Code
CCW
Regulation Number
868.5540
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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§ 868.5540 Rigid laryngoscope.

(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(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 § 868.9