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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K111885
Device Name SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
Applicant
RESPIRONICS INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Applicant Contact JOSEPH E OLSAVSKY
Correspondent
RESPIRONICS INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Correspondent Contact JOSEPH E OLSAVSKY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/01/2011
Decision Date 11/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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