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FDA 510(k), K123400, AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
FDA 510(k), K123400, AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
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510(K) Number: K123400
Device Name: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
Manufacturer: DARRYL FISCHER
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: 11/05/2012
Date Received: 05/16/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
Manufacturer: DARRYL FISCHER
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: 11/05/2012
Date Received: 05/16/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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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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