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FDA 510(k), K142969, ANI Monitor
FDA 510(k), K142969, ANI Monitor
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510(K) Number: K142969
Device Name: ANI Monitor
Manufacturer: MDOLORIS MEDICAL SYSTEMS SAS
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 10/14/2014
Decision Date: 02/23/2016
Regulation Medical Specialty: Cardiovascular
Device Name: ANI Monitor
Manufacturer: MDOLORIS MEDICAL SYSTEMS SAS
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 10/14/2014
Decision Date: 02/23/2016
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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