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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K911328
Device Name UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
Applicant
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Applicant Contact DEBRA E ROGERS
Correspondent
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Correspondent Contact DEBRA E ROGERS
Regulation Number868.5975
Classification Product Code
BZO  
Date Received03/26/1991
Decision Date 08/15/1991
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
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