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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K083093
Device Name CHEETAH RELIANT
Applicant
CHEETAH MEDICAL INC.
12154 DARNESTOWN RD. #236
GAITHERSBURG,  MD  20878
Applicant Contact Rhona Shanker
Correspondent
CHEETAH MEDICAL INC.
12154 DARNESTOWN RD. #236
GAITHERSBURG,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number870.2770
Classification Product Code
DSB  
Subsequent Product Code
DXN  
Date Received10/17/2008
Decision Date 12/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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