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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K941970
Device Name FAST-PATCH
Applicant
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Applicant Contact SHERRI L POCOCK
Correspondent
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Correspondent Contact SHERRI L POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received04/22/1994
Decision Date 12/07/1994
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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