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FDA 510(k)

Electronic Thermometer

K-Number: K152739 · 2016-02-09

Decision Date2016-02-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Electronic Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K152739. 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 Electronic Thermometer?

Electronic Thermometer is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K152739.

When did Electronic Thermometer receive FDA 510(k) clearance?

Electronic Thermometer received FDA 510(k) clearance on 2016-02-09, under 510(k) number K152739.

Who is the listed applicant for Electronic Thermometer?

The FDA 510(k) record lists Guangdong Biolight Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Thermometer?

The FDA product code for Electronic Thermometer is FLL.

Other records listing Guangdong Biolight Meditech Co., Ltd. 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.