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FDA 510(k)

INFRARED EAR THEMOMETER, MODELS DX6603, DX66390

K-Number: K051251 · 2005-09-07

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2005-09-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2005-09-07 under 510(k) number K051251. 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 INFRARED EAR THEMOMETER, MODELS DX6603, DX66390?

INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 is a medical device that received FDA 510(k) clearance on 2005-09-07. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K051251.

When did INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 receive FDA 510(k) clearance?

INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 received FDA 510(k) clearance on 2005-09-07, under 510(k) number K051251.

Who is the listed applicant for INFRARED EAR THEMOMETER, MODELS DX6603, DX66390?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFRARED EAR THEMOMETER, MODELS DX6603, DX66390?

The FDA product code for INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 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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