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FDA 510(k)

THERMOSCAN INSTANT THERMOMETER MODEL IR-6000

K-Number: K954523 · 1996-12-10

ApplicantThermoscan, Inc.
Decision Date1996-12-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 is the device name listed in this FDA 510(k) record. The listed applicant is Thermoscan, Inc.. It received FDA 510(k) clearance on 1996-12-10 under 510(k) number K954523. 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 THERMOSCAN INSTANT THERMOMETER MODEL IR-6000?

THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 is a medical device that received FDA 510(k) clearance on 1996-12-10. The listed applicant is Thermoscan, Inc.. The 510(k) number is K954523.

When did THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 receive FDA 510(k) clearance?

THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 received FDA 510(k) clearance on 1996-12-10, under 510(k) number K954523.

Who is the listed applicant for THERMOSCAN INSTANT THERMOMETER MODEL IR-6000?

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

What is the FDA product code for THERMOSCAN INSTANT THERMOMETER MODEL IR-6000?

The FDA product code for THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 is FLL.

Related Clinical Trials

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Other records listing Thermoscan, 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.

K964605BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)K930680THERMOSCAN INSTANT THERMOMETER IR-5000K902912THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000K896952THERMOSCAN-INSTANT THERMOMETER MODEL IR-2000

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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