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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 K020641
Device Name SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
Applicant
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
3178 KEEN DR.
WAYCROSS,  GA  31503
Applicant Contact JONATHAN LEE
Correspondent
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
3178 KEEN DR.
WAYCROSS,  GA  31503
Correspondent Contact JONATHAN LEE
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/27/2002
Decision Date 10/29/2002
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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