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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 K972829
Device Name CRICKET 2000 RECORDING PULSE OXIMETER
Applicant
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact FRANCIS X DOBSCHA
Correspondent
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact FRANCIS X DOBSCHA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/30/1997
Decision Date 10/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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