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FDA 510(k)

RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES

K-Number: K030324 · 2003-02-27

ApplicantRadiant Innovation, Inc.
Decision Date2003-02-27
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2003-02-27 under 510(k) number K030324. 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 RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES?

RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES is a medical device that received FDA 510(k) clearance on 2003-02-27. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K030324.

When did RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES receive FDA 510(k) clearance?

RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES received FDA 510(k) clearance on 2003-02-27, under 510(k) number K030324.

Who is the listed applicant for RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES?

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

What is the FDA product code for RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES?

The FDA product code for RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES is FLL.

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Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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