FDA.reportPublic FDA data

510(k) K811397

Device
Eca
Applicant
GILLCO, INC.
510(k) number
K811397
Product code
FOA
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-02
Date received
1981-05-18
Regulation
880.6080
Classification name
Board, Cardiopulmonary
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FOA#

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K221901EleGARDAdvancedcpr Solutions, LLC2022-07-29
K191689EleGARD Patient Positioning SystemMinnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio2020-02-13