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FDA 510(k) Application Details - K211941
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K211941
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
Energetic Designs, Inc.
3037 Grizzly Peak Dr.
Broomfield, CO 80023 US
Other 510(k) Applications for this Company
Contact
Kathy Fortin
Other 510(k) Applications for this Contact
Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/23/2021
Decision Date
01/27/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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