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510(k) K222496

Electromed SmartVest Airway Clearance System by Electromed, Inc. — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2022
Date Received
August 18, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

Other clearances by Electromed, Inc.

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  • K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL (December 1, 2005)
  • K040367 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ (April 7, 2004)
  • K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 (June 1, 1999)
  • K990813 — REHCOR (April 12, 1999)

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  • K173603 — Monarch Airway Clearance System (October 24, 2018)
  • K163378 — Monarch Airway Clearance System (March 17, 2017)
  • K142482 — The Vest Airway Clearance System (May 7, 2015)
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