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FDA 510(k)

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

K-Number: K152402 · 2016-03-04

ApplicantSecurus,Inc
Decision Date2016-03-04
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) is the device name listed in this FDA 510(k) record. The listed applicant is Securus,Inc. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K152402. 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 IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)?

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Securus,Inc. The 510(k) number is K152402.

When did IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) receive FDA 510(k) clearance?

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152402.

Who is the listed applicant for IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)?

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

What is the FDA product code for IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)?

The FDA product code for IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) is FLL.

Related Clinical Trials

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.

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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.

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Official Source

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