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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K121705
Device Name GEO
Applicant
Resmed, Ltd.
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Applicant Contact JIM CASSI
Correspondent
Resmed, Ltd.
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact JIM CASSI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/08/2012
Decision Date 10/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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