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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K001708
Device Name PROFOX SOFTWARE, MODEL 920M-41
Applicant
Respironics Georgia, Inc.
1255 Kennestone Cir.
Marietta,  GA  30066
Applicant Contact GERRY RICHARDSON
Correspondent
Respironics Georgia, Inc.
1255 Kennestone Cir.
Marietta,  GA  30066
Correspondent Contact GERRY RICHARDSON
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/05/2000
Decision Date 03/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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