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FDA 510(k)

PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007

K-Number: K012974 · 2002-07-23

ApplicantPrizm Medical, Inc.
Decision Date2002-07-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 is the device name listed in this FDA 510(k) record. The listed applicant is Prizm Medical, Inc.. It received FDA 510(k) clearance on 2002-07-23 under 510(k) number K012974. 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 PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007?

PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 is a medical device that received FDA 510(k) clearance on 2002-07-23. The listed applicant is Prizm Medical, Inc.. The 510(k) number is K012974.

When did PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 receive FDA 510(k) clearance?

PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 received FDA 510(k) clearance on 2002-07-23, under 510(k) number K012974.

Who is the listed applicant for PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007?

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

What is the FDA product code for PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007?

The FDA product code for PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 is FLL.

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Other records listing Prizm Medical, Inc. as applicant

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K0331225000Z SYSTEM (OTC)K032239THERA-CREAM, MODEL TCT004K024181PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEMK951727Z-WATCH SYSTEMK944487ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODESK932299ELECTRO-MESH

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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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