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FDA 510(k)

AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)

K-Number: K010462 · 2001-04-11

ApplicantAvita Corporation
Decision Date2001-04-11
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 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 2001-04-11 under 510(k) number K010462. 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 PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)?

AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) is a medical device that received FDA 510(k) clearance on 2001-04-11. The listed applicant is Avita Corporation. The 510(k) number is K010462.

When did AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) receive FDA 510(k) clearance?

AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) received FDA 510(k) clearance on 2001-04-11, under 510(k) number K010462.

Who is the listed applicant for AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 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 PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)?

The FDA product code for AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 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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