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FDA 510(k), K162571, Bioflux Software
FDA 510(k), K162571, Bioflux Software
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510(K) Number: K162571
Device Name: Bioflux Software
Manufacturer: Tom Elias
Device Classification Name: Recorder, Magnetic Tape, Medical
Regulation Number: DSH
Classification Product Code: KXA
Date Received: 09/15/2016
Decision Date: 10/13/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Bioflux Software
Manufacturer: Tom Elias
Device Classification Name: Recorder, Magnetic Tape, Medical
Regulation Number: DSH
Classification Product Code: KXA
Date Received: 09/15/2016
Decision Date: 10/13/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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