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FDA 510(k)

AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES

K-Number: K092958 · 2009-12-02

ApplicantAvita Corporation
Decision Date2009-12-02
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2009-12-02 under 510(k) number K092958. 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 AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES?

AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES is a medical device that received FDA 510(k) clearance on 2009-12-02. The listed applicant is Avita Corporation. The 510(k) number is K092958.

When did AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES receive FDA 510(k) clearance?

AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES received FDA 510(k) clearance on 2009-12-02, under 510(k) number K092958.

Who is the listed applicant for AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES?

The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES?

The FDA product code for AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES is FLL.

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Related Devices (Code: 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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