TEMPORALSCANNER THERMOMETER, SENSORTOUCH

Thermometer, Electronic, Clinical

EXERGEN CORP.

The following data is part of a premarket notification filed by Exergen Corp. with the FDA for Temporalscanner Thermometer, Sensortouch.

Pre-market Notification Details

• Device ID: K011291
• 510k Number: K011291
• Device Name: TEMPORALSCANNER THERMOMETER, SENSORTOUCH
• Classification: Thermometer, Electronic, Clinical
• Applicant: EXERGEN CORP. 601 13TH STREET, NW Washington, DC 20005
• Contact: William Hare
• Correspondent: William Hare; EXERGEN CORP. 601 13TH STREET, NW Washington, DC 20005
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-27
• Decision Date: 2001-07-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10834098000966	K011291	000
10834098000591	K011291	000
10834098000539	K011291	000
10834098000089	K011291	000
10834098000102	K011291	000
10834098000126	K011291	000
10834098000133	K011291	000
10834098000140	K011291	000
10834098000157	K011291	000
10834098000164	K011291	000
10834098000171	K011291	000
10834098000188	K011291	000
00834098003021	K011291	000
00834098000907	K011291	000
10834098000577	K011291	000
10834098000973	K011291	000
10834098000607	K011291	000
10834098000614	K011291	000
10834098000621	K011291	000
10834098000850	K011291	000
10834098000867	K011291	000
10834098000874	K011291	000
10834098000881	K011291	000
10834098000546	K011291	000
10834098000553	K011291	000
10834098000560	K011291	000
10834098000195	K011291	000
10834098000201	K011291	000
10834098000515	K011291	000
10834098002021	K011291	000
10834098002038	K011291	000
10834098002045	K011291	000
10834098002052	K011291	000
10834098002069	K011291	000
10834098002106	K011291	000
30834098002315	K011291	000
00834098002918	K011291	000
50834098002920	K011291	000
00834098002949	K011291	000
10834098000492	K011291	000
10834098000485	K011291	000
10834098000478	K011291	000
10834098000218	K011291	000
10834098000225	K011291	000
10834098000232	K011291	000
10834098000249	K011291	000
10834098000256	K011291	000
10834098000263	K011291	000
10834098000270	K011291	000
10834098000287	K011291	000
10834098000294	K011291	000
10834098000300	K011291	000
10834098000317	K011291	000
00834098002956	K011291	000