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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K131253
Device Name PERIFLUX 6000
Applicant
PERIMED AB
DATAVAGEN 9 A
JARFALLA,  SE 17543
Applicant Contact MARIA LILJEVRET
Correspondent
PERIMED AB
DATAVAGEN 9 A
JARFALLA,  SE 17543
Correspondent Contact MARIA LILJEVRET
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Codes
KLK   LPP  
Date Received05/02/2013
Decision Date 10/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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