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FDA 510(k)

OMRON MODEL 514N TYMPANIC THERMOMETER

K-Number: K051233 · 2005-06-21

ApplicantOmron Healthcare, Inc.
Decision Date2005-06-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMRON MODEL 514N TYMPANIC THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2005-06-21 under 510(k) number K051233. 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 OMRON MODEL 514N TYMPANIC THERMOMETER?

OMRON MODEL 514N TYMPANIC THERMOMETER is a medical device that received FDA 510(k) clearance on 2005-06-21. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K051233.

When did OMRON MODEL 514N TYMPANIC THERMOMETER receive FDA 510(k) clearance?

OMRON MODEL 514N TYMPANIC THERMOMETER received FDA 510(k) clearance on 2005-06-21, under 510(k) number K051233.

Who is the listed applicant for OMRON MODEL 514N TYMPANIC THERMOMETER?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMRON MODEL 514N TYMPANIC THERMOMETER?

The FDA product code for OMRON MODEL 514N TYMPANIC THERMOMETER is FLL.

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Official Source

View on FDA Database →

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

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