FDA 510(k), K143067, Carnation Ambulatory Monitor
FDA 510(k), K143067, Carnation Ambulatory Monitor
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510(K) Number: K143067
Device Name: Carnation Ambulatory Monitor
Manufacturer: JON P. HUNT
Device Classification Name: Recorder, Magnetic Tape, Medical
Regulation Number: DSH
Classification Product Code: 10/24/2014
Date Received: 12/22/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Carnation Ambulatory Monitor
Manufacturer: JON P. HUNT
Device Classification Name: Recorder, Magnetic Tape, Medical
Regulation Number: DSH
Classification Product Code: 10/24/2014
Date Received: 12/22/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- 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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