DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9

Thermometer, Electronic, Clinical

VEGA TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Vega Technologies, Inc. with the FDA for Digital Thermometer, Models Mt-xx8 And Mt-xx9.

Pre-market Notification Details

• Device ID: K041516
• 510k Number: K041516
• Device Name: DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
• Classification: Thermometer, Electronic, Clinical
• Applicant: VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104
• Contact: Joseph Lu
• Correspondent: Joseph Lu; VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-06-04
• Decision Date: 2004-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10032251921619	K041516	000
00845717002547	K041516	000
00845717002554	K041516	000
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00845717002530	K041516	000
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10849027002546	K041516	000
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10767056158020	K041516	000
00635515992207	K041516	000