MT ALERT INFUSION MONITOR— 510(k) K013121

Name: FDA 510(k) clearance K013121
Creator: U.S. Food and Drug Administration
Published: 2001-10-15

Substantially Equivalent

Sierra Biosearch, Inc.

FDA 510(k) clearance K013121 for MT ALERT INFUSION MONITOR, Substantially Equivalent on 2001-10-15. Applicant: Sierra Biosearch, Inc.. Device class: 2.

Clearance details

Applicant: Sierra Biosearch, Inc.
Product code: Code FLN
Device class: Class 2
Regulation: 21 CFR 880.2420
Advisory panel: General Hospital
Date received: 2001-09-18
Decision date: 2001-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bishop, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.