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FDA 510(k)

CRIT-LINE MONITOR III TQA (CLM TQA)

K-Number: K011741 · 2002-07-23

ApplicantHemametrics
Decision Date2002-07-23
Product CodeFIL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CRIT-LINE MONITOR III TQA (CLM TQA) is the device name listed in this FDA 510(k) record. The listed applicant is Hemametrics. It received FDA 510(k) clearance on 2002-07-23 under 510(k) number K011741. The device is classified under product code FIL. It was reviewed by the GU advisory panel. Product code FIL falls under the category of Radiology, which covers imaging devices and accessories used in diagnostic radiology. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRIT-LINE MONITOR III TQA (CLM TQA)?

CRIT-LINE MONITOR III TQA (CLM TQA) is a medical device that received FDA 510(k) clearance on 2002-07-23. The listed applicant is Hemametrics. The 510(k) number is K011741.

When did CRIT-LINE MONITOR III TQA (CLM TQA) receive FDA 510(k) clearance?

CRIT-LINE MONITOR III TQA (CLM TQA) received FDA 510(k) clearance on 2002-07-23, under 510(k) number K011741.

Who is the listed applicant for CRIT-LINE MONITOR III TQA (CLM TQA)?

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

What is the FDA product code for CRIT-LINE MONITOR III TQA (CLM TQA)?

The FDA product code for CRIT-LINE MONITOR III TQA (CLM TQA) is FIL. This falls under the Radiology category.

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Related Devices (Code: FIL)

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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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