DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9— 510(k) K041516

Substantially Equivalent

Vega Technologies, Inc.

FDA 510(k) clearance K041516 for DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9, Substantially Equivalent on 2004-09-08. Applicant: Vega Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Vega Technologies, Inc.
Product code
Code FLL
Device class
Class 2
Regulation
21 CFR 880.2910
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taipei, TW
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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