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FDA 510(k)

DIATEK 500

K-Number: K790416 · 1979-04-10

ApplicantDiatek, Inc.
Decision Date1979-04-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIATEK 500 is the device name listed in this FDA 510(k) record. The listed applicant is Diatek, Inc.. It received FDA 510(k) clearance on 1979-04-10 under 510(k) number K790416. 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 DIATEK 500?

DIATEK 500 is a medical device that received FDA 510(k) clearance on 1979-04-10. The listed applicant is Diatek, Inc.. The 510(k) number is K790416.

When did DIATEK 500 receive FDA 510(k) clearance?

DIATEK 500 received FDA 510(k) clearance on 1979-04-10, under 510(k) number K790416.

Who is the listed applicant for DIATEK 500?

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

What is the FDA product code for DIATEK 500?

The FDA product code for DIATEK 500 is FLL.

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Other records listing Diatek, 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.

K020430DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)K010399DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)K895703DIATEK MODEL 700 THERMOMETERK872178MODIFICATION TO ARKIVE(TM)K862085ARKIVE (TM)K841827ENTEROPORT NUTRITION PUMP

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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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