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FDA 510(k)

MYOCARDIAL PROBE THERMOMETER CODE 64000

K-Number: K893418 · 1989-09-05

ApplicantDlp, Inc.
Decision Date1989-09-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MYOCARDIAL PROBE THERMOMETER CODE 64000 is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K893418. 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 MYOCARDIAL PROBE THERMOMETER CODE 64000?

MYOCARDIAL PROBE THERMOMETER CODE 64000 is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Dlp, Inc.. The 510(k) number is K893418.

When did MYOCARDIAL PROBE THERMOMETER CODE 64000 receive FDA 510(k) clearance?

MYOCARDIAL PROBE THERMOMETER CODE 64000 received FDA 510(k) clearance on 1989-09-05, under 510(k) number K893418.

Who is the listed applicant for MYOCARDIAL PROBE THERMOMETER CODE 64000?

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

What is the FDA product code for MYOCARDIAL PROBE THERMOMETER CODE 64000?

The FDA product code for MYOCARDIAL PROBE THERMOMETER CODE 64000 is FLL.

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Other records listing Dlp, 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.

K973485CLEARVIEW BLOWER/MISTERK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETK950754MACRO SUCTION TUBE MODEL NO 10061K934215CONTAIN-ORK915268CATHETER TWO STAGE VENOUS RETURN

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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

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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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