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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 K103166
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 Codes
DQA   DXN  
Date Received10/27/2010
Decision Date 01/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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