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FDA 510(k)

SD-100 SKYEAR THERMOMETER

K-Number: K984506 · 1999-07-29

ApplicantSkylark Device Co., Ltd.
Decision Date1999-07-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SD-100 SKYEAR THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device Co., Ltd.. It received FDA 510(k) clearance on 1999-07-29 under 510(k) number K984506. 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 SD-100 SKYEAR THERMOMETER?

SD-100 SKYEAR THERMOMETER is a medical device that received FDA 510(k) clearance on 1999-07-29. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K984506.

When did SD-100 SKYEAR THERMOMETER receive FDA 510(k) clearance?

SD-100 SKYEAR THERMOMETER received FDA 510(k) clearance on 1999-07-29, under 510(k) number K984506.

Who is the listed applicant for SD-100 SKYEAR THERMOMETER?

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

What is the FDA product code for SD-100 SKYEAR THERMOMETER?

The FDA product code for SD-100 SKYEAR THERMOMETER is FLL.

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Other records listing Skylark Device Co., Ltd. as applicant

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K990233ST-302 INFRAREXK981449SD-956 ULTRASOUND THERAPYK983964BATCH #6060 CONDUCTIVE GELK964437GB-1002 TENS WITH MASSAGEK974585IF-727 INTERFERENTIAL STIMULATORK964434SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

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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

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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