FDA 510(k) Application Details - K222496

Device Classification Name Percussor, Powered-Electric

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510(K) Number K222496
Device Name Percussor, Powered-Electric
Applicant Electromed, Inc.
500 Sixth Ave NW
New Prague, MN 56071 US
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Contact Gregory Spurlock
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 08/18/2022
Decision Date 11/18/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K222496


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