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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 K915773
Device Name P-300 CAPNOGRAPH AND PULSE OXIMETER
Applicant
Pryon Corp.
N93 W14575 Whittaker Way
Menomonee Falls,  WI  53051
Applicant Contact SANDRA L SCHICK
Correspondent
Pryon Corp.
N93 W14575 Whittaker Way
Menomonee Falls,  WI  53051
Correspondent Contact SANDRA L SCHICK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/24/1991
Decision Date 06/24/1992
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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