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FDA 510(k)

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

K-Number: K161933 · 2016-08-16

Decision Date2016-08-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2016-08-16 under 510(k) number K161933. 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 The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a medical device that received FDA 510(k) clearance on 2016-08-16. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K161933.

When did The Braun ThermoScan® 3 High Speed Compact Ear Thermometer receive FDA 510(k) clearance?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer received FDA 510(k) clearance on 2016-08-16, under 510(k) number K161933.

Who is the listed applicant for The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The FDA 510(k) record lists Kaz USA, Inc., A Helen of Troy Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The FDA product code for The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is FLL.

Other records listing Kaz USA, Inc., A Helen of Troy Company as applicant

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.

View all 8 devices →

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.

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.