Retinoscope, Battery-powered

Device Code: 4171

Product Code(s): HKM

Device Classification Information

• Device Type ID: 4171
• Device Name: Retinoscope, Battery-powered
• Regulation Description: Retinoscope.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Diagnostic And Surgical Devices Branch (DSDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 886.1780 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: HKM
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 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
• 10-102 ANSI Z80.36-2016
  American National Standard For Ophthalmics - Light Hazard Protection For Ophthalmic Instruments

Total Product Life Cycle

• Device Type ID: 4171
• Device: Retinoscope, Battery-powered
• Product Code: HKM
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Retinoscope.
• CFR Regulation Number: 886.1780 [🔎]

TPLC Last Update: 2019-04-02 20:44:09