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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K980052
Device Name RESPAIDE
Applicant
Emergency Filtration Products, Inc.
321 N. Mall Dr.
Suite H103
St. George,  UT  84790
Applicant Contact MICHAEL J CRNKOVICH
Correspondent
Emergency Filtration Products, Inc.
321 N. Mall Dr.
Suite H103
St. George,  UT  84790
Correspondent Contact MICHAEL J CRNKOVICH
Regulation Number868.5870
Classification Product Code
CBP  
Date Received01/06/1998
Decision Date 08/05/1998
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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