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FDA 510(k)

ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE

K-Number: K880639 · 1988-11-02

ApplicantHuman Technologies, Inc.
Decision Date1988-11-02
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE is the device name listed in this FDA 510(k) record. The listed applicant is Human Technologies, Inc.. It received FDA 510(k) clearance on 1988-11-02 under 510(k) number K880639. 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 ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE?

ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE is a medical device that received FDA 510(k) clearance on 1988-11-02. The listed applicant is Human Technologies, Inc.. The 510(k) number is K880639.

When did ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE receive FDA 510(k) clearance?

ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE received FDA 510(k) clearance on 1988-11-02, under 510(k) number K880639.

Who is the listed applicant for ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE?

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

What is the FDA product code for ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE?

The FDA product code for ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE is FLL.

Related Clinical Trials

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Other records listing Human Technologies, 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.

K871158SIBIS REMOTE ACTUATORK871203BED PATIENT PRESENCE MONITOR

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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