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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K992384
Device Name CPAP/PRO CPAP INTERFACE
Applicant
STEVENSON INDUSTRIES, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523
Applicant Contact DAVID W SCHLERF
Correspondent
STEVENSON INDUSTRIES, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523
Correspondent Contact DAVID W SCHLERF
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/16/1999
Decision Date 12/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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