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FDA 510(k), K182963, emFieldPro
FDA 510(k), K182963, emFieldPro
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510(K) Number: K182963
Device Name: emFieldPro
Manufacturer: Ute Hauss
Device Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation Number: NGX
Classification Product Code: KXA
Date Received: 10/25/2018
Decision Date: 06/21/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: emFieldPro
Manufacturer: Ute Hauss
Device Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation Number: NGX
Classification Product Code: KXA
Date Received: 10/25/2018
Decision Date: 06/21/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
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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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