Laryngostroboscope

Device Code: 1445

Product Code(s): EQL

Device Classification Information

• Device Type ID: 1445
• Device Name: Laryngostroboscope
• Regulation Description: Laryngostroboscope.
• 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: 874.4750 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EQL
• 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

Total Product Life Cycle

• Device Type ID: 1445
• Device: Laryngostroboscope
• Product Code: EQL
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Laryngostroboscope.
• CFR Regulation Number: 874.4750 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	5
Total Device Problems	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Pentax Medical Company	II	Jun-28-2016
2	Pentax Of America Inc	II	Jan-23-2017

TPLC Last Update: 2019-04-02 19:54:08