LARYNGEAL STROBE
N/A - 9400
Device Description
A device used to observe and record the intralaryngeal phenomenon of phonation (speech). It is comprised of a number of components, e.g., a rhino-laryngeal stroboscope unit, camera, video recorder, computer and software, and will typically be used together with an appropriate endoscope. It is typically used in ear/nose/throat (ENT) departments to investigate the correct functioning of the vocal apparatus (glottis) and to investigate voice disorders.
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
