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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K903657
Device Name MODEL 610 MODIFIED
Applicant
First Medical Devices Corp.
11810 115th Ave. NE
Kirkland,  WA  98034
Applicant Contact RAYMOND W GIFFORD
Correspondent
First Medical Devices Corp.
11810 115th Ave. NE
Kirkland,  WA  98034
Correspondent Contact RAYMOND W GIFFORD
Regulation Number870.5300
Classification Product Code
LDD  
Date Received08/09/1990
Decision Date 09/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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