FDA 510(k)

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1

K-Number: K091040 · 2009-05-13

ApplicantMicrolife Intellectual Property GmbH

Decision Date2009-05-13

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2009-05-13 under 510(k) number K091040. 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 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1?

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 is a medical device that received FDA 510(k) clearance on 2009-05-13. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K091040.

When did MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 receive FDA 510(k) clearance?

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 received FDA 510(k) clearance on 2009-05-13, under 510(k) number K091040.

Who is the listed applicant for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1?

The FDA product code for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 is 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.