FDA 510(k)

HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES

K-Number: K081061 · 2008-07-18

Decision Date2008-07-18

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Harvard Medical Devices , Ltd.. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K081061. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES?

HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Harvard Medical Devices , Ltd.. The 510(k) number is K081061.

When did HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES receive FDA 510(k) clearance?

HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES received FDA 510(k) clearance on 2008-07-18, under 510(k) number K081061.

Who is the listed applicant for HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES?

The FDA 510(k) record lists Harvard Medical Devices , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES?

The FDA product code for HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES is FLL.

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Other records listing Harvard Medical Devices , Ltd. as applicant

K100620FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 K092558WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES K092557DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES K081159HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES

Related Devices (Code: FLL)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.