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FDA 510(k)

GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE

K-Number: K121999 · 2013-02-28

ApplicantDraeger Medical GmbH
Decision Date2013-02-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical GmbH. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K121999. 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 GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE?

GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Draeger Medical GmbH. The 510(k) number is K121999.

When did GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE receive FDA 510(k) clearance?

GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE received FDA 510(k) clearance on 2013-02-28, under 510(k) number K121999.

Who is the listed applicant for GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE?

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

What is the FDA product code for GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE?

The FDA product code for GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE is FLL.

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Other records listing Draeger Medical GmbH as applicant

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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.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

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.

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