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MindChild Medical, Inc. Announces filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the MERIDIAN™ M110 Line of Non- Invasive Fetal Heart Rate Monitors
Nov. 15, 2015
Courtesy ofMindchild Medical, Inc.
(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has filed a 510(k) pre-market notification with the US Food and Drug Administration (FDA) for its MERIDIAN Model M110 non-invasive Fetal Heart Monitor1,2,3 . MindChild previously announced 510(k) pre-market clearance of the MERIDIAN M100 fetal monitor. MindChild anticipates entering the US market with the MERIDIAN family of fetal monitor products following the FDA pre-market clearance of the current 510(k) notification. Additional pre- market regulatory filings are anticipated during 2016.
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