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FDA 510(k)

MT ALERT INFUSION MONITOR

K-Number: K013121 · 2001-10-15

ApplicantSierra Biosearch, Inc.
Decision Date2001-10-15
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MT ALERT INFUSION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Biosearch, Inc.. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K013121. The device is classified under product code FLN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MT ALERT INFUSION MONITOR?

MT ALERT INFUSION MONITOR is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Sierra Biosearch, Inc.. The 510(k) number is K013121.

When did MT ALERT INFUSION MONITOR receive FDA 510(k) clearance?

MT ALERT INFUSION MONITOR received FDA 510(k) clearance on 2001-10-15, under 510(k) number K013121.

Who is the listed applicant for MT ALERT INFUSION MONITOR?

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

What is the FDA product code for MT ALERT INFUSION MONITOR?

The FDA product code for MT ALERT INFUSION MONITOR is FLN.

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Related Devices (Code: FLN)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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