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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K973545
Device Name VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
Applicant
Vacumed, Div. Of Vacumetrics, Inc.
2225 E. Murray Holladay Rd.
Suite 207
Salt Lake City,  UT  84117
Applicant Contact RAE NADINE SMITH
Correspondent
Vacumed, Div. Of Vacumetrics, Inc.
2225 E. Murray Holladay Rd.
Suite 207
Salt Lake City,  UT  84117
Correspondent Contact RAE NADINE SMITH
Regulation Number868.1720
Classification Product Code
CCL  
Date Received09/18/1997
Decision Date 05/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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