No-contact Forehead Thermometer

Thermometer, Electronic, Clinical

Dongguan SIMZO Electronic Technology Co.Ltd.

The following data is part of a premarket notification filed by Dongguan Simzo Electronic Technology Co.ltd. with the FDA for No-contact Forehead Thermometer.

Pre-market Notification Details

• Device ID: K173048
• 510k Number: K173048
• Device Name: No-contact Forehead Thermometer
• Classification: Thermometer, Electronic, Clinical
• Applicant: Dongguan SIMZO Electronic Technology Co.Ltd. No.81, Tianxin Street, Chongkong, Shijie Town Dongguan, CN
• Contact: Mei Mei
• Correspondent: Mei Mei; Dongguan SIMZO Electronic Technology Co.Ltd. No.81, Tianxin Street, Chongkong, Shijie Town Dongguan, CN
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-28
• Decision Date: 2018-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810021178394	K173048	000
00810021171043	K173048	000
00810021171050	K173048	000
00810021171067	K173048	000
00810021171074	K173048	000
00810021171081	K173048	000
00810021171098	K173048	000
00810021171104	K173048	000
00810021171111	K173048	000
00810021171128	K173048	000
00810021171135	K173048	000
10810021171149	K173048	000
10810021178018	K173048	000
10810021178049	K173048	000
10810021178056	K173048	000
10810021178063	K173048	000
10810021178070	K173048	000
10810021171033	K173048	000
00810021171029	K173048	000
00810021171012	K173048	000
00810021171166	K173048	000
00810021171173	K173048	000
00810021171180	K173048	000
00810021171197	K173048	000
00810021171203	K173048	000
00810021171210	K173048	000
00810021171227	K173048	000
00810021171234	K173048	000
00810021171241	K173048	000
00810021171258	K173048	000
00810021171265	K173048	000
00810021171272	K173048	000
10810021178384	K173048	000
10810021178391	K173048	000
10810021178377	K173048	000
10810021178360	K173048	000
10810021178087	K173048	000
10810021178094	K173048	000
10810021178100	K173048	000
10810021178315	K173048	000
10810021178339	K173048	000
10810021178346	K173048	000
10810021178353	K173048	000
18100211780193	K173048	000
18100211780209	K173048	000
18100211780216	K173048	000
18100211780223	K173048	000
18100211780230	K173048	000
18100211780247	K173048	000
18100211780254	K173048	000
18100211780261	K173048	000
28100211780176	K173048	000
08100211780141	K173048	000
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08100211710148	K173048	000
10810021178308	K173048	000
10810021178292	K173048	000
10810021178285	K173048	000
10810021178117	K173048	000
10810021178124	K173048	000
10810021178131	K173048	000
10810021178148	K173048	000
10810021178155	K173048	000
10810021178162	K173048	000
10810021178179	K173048	000
10810021178186	K173048	000
10810021178193	K173048	000
10810021178209	K173048	000
10810021178216	K173048	000
10810021178223	K173048	000
10810021178230	K173048	000
10810021178247	K173048	000
10810021178254	K173048	000
10810021178278	K173048	000
08100211710094	K173048	000