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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K970365
Device Name PASSY-MUIR O2 ADAPTER; PMA2000
Applicant
Passy-Muir, Inc.
4521 Campus Dr., Suite 273
Irvine,  CA  92612
Applicant Contact PATRICIA E PASSY
Correspondent
Passy-Muir, Inc.
4521 Campus Dr., Suite 273
Irvine,  CA  92612
Correspondent Contact PATRICIA E PASSY
Regulation Number868.5800
Classification Product Code
JOH  
Date Received01/31/1997
Decision Date 02/12/1997
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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