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FDA 510(k)

DIOTHERM

K-Number: K895137 · 1990-11-16

ApplicantScience Regulatory Services Intl.
Decision Date1990-11-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIOTHERM is the device name listed in this FDA 510(k) record. The listed applicant is Science Regulatory Services Intl.. It received FDA 510(k) clearance on 1990-11-16 under 510(k) number K895137. 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 DIOTHERM?

DIOTHERM is a medical device that received FDA 510(k) clearance on 1990-11-16. The listed applicant is Science Regulatory Services Intl.. The 510(k) number is K895137.

When did DIOTHERM receive FDA 510(k) clearance?

DIOTHERM received FDA 510(k) clearance on 1990-11-16, under 510(k) number K895137.

Who is the listed applicant for DIOTHERM?

The FDA 510(k) record lists Science Regulatory Services Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIOTHERM?

The FDA product code for DIOTHERM is FLL.

Related Clinical Trials

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Other records listing Science Regulatory Services Intl. 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.

K910178ACTH IRMA KIT MITSUBISHI YUKA

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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