LARYNGEAL STROBE
N/A - 9400
Device Description
A device that is intended to allow the observation of glottic action during phonation (speech) in the examination of voice disorders. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. It can contain a microphone that captures the acoustic signals from the glottic area and may or may not contact the patient.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: EQL
Device Name: Laryngostroboscope
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: EN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 874.4750
Third Party Flag: N
Medical Specialty: EN
Device Identifiers
Device Id: 04961333240685
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
