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FDA 510(k)

COPAL DIGITAL THERMOMETER UF-12

K-Number: K850195 · 1985-02-07

ApplicantTakeda Medical, Inc.
Decision Date1985-02-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COPAL DIGITAL THERMOMETER UF-12 is the device name listed in this FDA 510(k) record. The listed applicant is Takeda Medical, Inc.. It received FDA 510(k) clearance on 1985-02-07 under 510(k) number K850195. 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 COPAL DIGITAL THERMOMETER UF-12?

COPAL DIGITAL THERMOMETER UF-12 is a medical device that received FDA 510(k) clearance on 1985-02-07. The listed applicant is Takeda Medical, Inc.. The 510(k) number is K850195.

When did COPAL DIGITAL THERMOMETER UF-12 receive FDA 510(k) clearance?

COPAL DIGITAL THERMOMETER UF-12 received FDA 510(k) clearance on 1985-02-07, under 510(k) number K850195.

Who is the listed applicant for COPAL DIGITAL THERMOMETER UF-12?

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

What is the FDA product code for COPAL DIGITAL THERMOMETER UF-12?

The FDA product code for COPAL DIGITAL THERMOMETER UF-12 is FLL.

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Other records listing Takeda Medical, Inc. 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.

K854797TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731K853158DIGITAL SPHYGMOMANOMETER MODEL 7620K851223COPAL DIGITAL SPHYGMOMANOMETER UA-560K852564COPAL UA-512 DIGITAL BLOOD PRESSURE MONITORK843390COPAL DIGITAL SPHYGMOMANOMETER UA-535K844285COPAL DIGITAL SPHYGMOMAMOMETER UA-550

View all 11 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.

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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