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510(k) K191689

EleGARD Patient Positioning System by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio — Product Code FOA

K191689 is an FDA 510(k) premarket notification submitted by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio for the device "EleGARD Patient Positioning System". The FDA issued a decision of Substantially Equivalent on February 13, 2020. The device falls under product code FOA (Board, Cardiopulmonary), a Class I device regulated under 21 CFR 880.6080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2020
Date Received
June 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Board, Cardiopulmonary
Device Class
Class I
Regulation Number
880.6080
Review Panel
HO
Submission Type

Other clearances for product code FOA

FDA data resources