Non-contact Infrared Thermometer

Thermometer, Electronic, Clinical

Alicn Medical (Shenzhen), Inc

The following data is part of a premarket notification filed by Alicn Medical (shenzhen), Inc with the FDA for Non-contact Infrared Thermometer.

Pre-market Notification Details

• Device ID: K180207
• 510k Number: K180207
• Device Name: Non-contact Infrared Thermometer
• Classification: Thermometer, Electronic, Clinical
• Applicant: Alicn Medical (Shenzhen), Inc 4/F, B Building, Shenfubao Modern Optical Factory Kengzi Street, Pingshan Dist Shezhen, CN 518122
• Contact: Meisong Fang
• Correspondent: Reanny Wang; Shenzhen Reanny Medical Devices Management Consulting Co, Lt Room 2012 Of Gebu Commercial Building, Hongxing, Songgang Baoan District Shenzhen, CN 518000
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-24
• Decision Date: 2018-11-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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MHC18601072	K180207	000
MHC18601062	K180207	000
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