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FDA 510(k)

CRIT-LINE ANEMIA MANAGEMENT SOFTWARE

K-Number: K093834 · 2010-09-29

ApplicantHema Metrics, LLC
Decision Date2010-09-29
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRIT-LINE ANEMIA MANAGEMENT SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Hema Metrics, LLC. It received FDA 510(k) clearance on 2010-09-29 under 510(k) number K093834. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRIT-LINE ANEMIA MANAGEMENT SOFTWARE?

CRIT-LINE ANEMIA MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2010-09-29. The listed applicant is Hema Metrics, LLC. The 510(k) number is K093834.

When did CRIT-LINE ANEMIA MANAGEMENT SOFTWARE receive FDA 510(k) clearance?

CRIT-LINE ANEMIA MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2010-09-29, under 510(k) number K093834.

Who is the listed applicant for CRIT-LINE ANEMIA MANAGEMENT SOFTWARE?

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

What is the FDA product code for CRIT-LINE ANEMIA MANAGEMENT SOFTWARE?

The FDA product code for CRIT-LINE ANEMIA MANAGEMENT SOFTWARE is MSQ.

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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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