EleGARD— 510(k) K221901

Substantially Equivalent

Advancedcpr Solutions, LLC

FDA 510(k) clearance K221901 for EleGARD, Substantially Equivalent on 2022-07-29. Applicant: Advancedcpr Solutions, LLC. Device class: 1.

Clearance details

Applicant
Advancedcpr Solutions, LLC
Product code
Code FOA
Device class
Class 1
Regulation
21 CFR 880.6080
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Edina, MN, US
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