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FDA 510(k), K100488, IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
FDA 510(k), K100488, IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
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510(K) Number: K100488
Device Name: IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Device Classification Name: thermometer, electronic, clinical
Regulation Number: 880.2910
Classification Product Code: FLL
Date Received: 02/19/2010
Decision Date: 07/22/2010
Regulation Medical Specialty: General Hospital
Device Name: IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Device Classification Name: thermometer, electronic, clinical
Regulation Number: 880.2910
Classification Product Code: FLL
Date Received: 02/19/2010
Decision Date: 07/22/2010
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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