MINE

Unit, X-ray, Extraoral With Timer

RHT Co., Ltd

The following data is part of a premarket notification filed by Rht Co., Ltd with the FDA for Mine.

Pre-market Notification Details

• Device ID: K180671
• 510k Number: K180671
• Device Name: MINE
• Classification: Unit, X-ray, Extraoral With Timer
• Applicant: RHT Co., Ltd 207, Cheomdangwagiro, 208 Bungil 50, Bukgu Gwangju, KR 61012
• Contact: Joon-ho Oh
• Correspondent: April Lee; Withus Group Inc 106 Superior Irvine, CA 92620
• Product Code: EHD
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-14
• Decision Date: 2019-06-05