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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K001430
Device Name RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
Applicant
VORTRAN MEDICAL TECHNOLOGY 1, INC.
3941 J ST.
SUITE 354
SACRAMENTO,  CA  95819
Applicant Contact GORDON A WONG
Correspondent
VORTRAN MEDICAL TECHNOLOGY 1, INC.
3941 J ST.
SUITE 354
SACRAMENTO,  CA  95819
Correspondent Contact GORDON A WONG
Regulation Number868.5925
Classification Product Code
BTL  
Date Received05/05/2000
Decision Date 07/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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