Source, Carrier, Fiberoptic Light

Device Code: 1443

Product Code(s): EQH

Device Classification Information

• Device Type ID: 1443
• Device Name: Source, Carrier, Fiberoptic Light
• Regulation Description: Ear, Nose, And Throat Fiberoptic Light Source And Carrier.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 874.4350 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EQH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 9-114 IEC 60601-2-18: Edition 3.0 2009-08
  Medical Electrical Equipment - Part 2-18: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment
• 10-65 ISO 15752 Second Edition 2010-01-15
  Ophthalmic Instruments - Endoilluminators - Fundamental Requirements And Test Methods For Optical Radiation Safety
• 10-72 ISO 15004-1 First Edition 2006-06-01
  Ophthalmic Instruments - Fundamental Requirements And Test Methods - Part 1: General Requirements Applicable To All Ophthalmic Instruments

Total Product Life Cycle

• Device Type ID: 1443
• Device: Source, Carrier, Fiberoptic Light
• Product Code: EQH
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Ear, Nose, And Throat Fiberoptic Light Source And Carrier.
• CFR Regulation Number: 874.4350 [🔎]

Device Problems
Smoking	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:54:06