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510(k) K221901

EleGARD by Advancedcpr Solutions, LLC — Product Code FOA

K221901 is an FDA 510(k) premarket notification submitted by Advancedcpr Solutions, LLC for the device "EleGARD". The FDA issued a decision of Substantially Equivalent on July 29, 2022. 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
July 29, 2022
Date Received
June 30, 2022
Clearance Type
Special
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

  • K191689 — EleGARD Patient Positioning System (February 13, 2020)
  • K811397 — ECA (July 2, 1981)

FDA data resources