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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K942125
Device Name VOLUME VENTILATOR
Applicant
Mag, Inc.
30 Robb Hill Rd.
Martinsville,  IN  46151
Applicant Contact ROD FYE
Correspondent
Mag, Inc.
30 Robb Hill Rd.
Martinsville,  IN  46151
Correspondent Contact ROD FYE
Regulation Number868.5240
Classification Product Code
CAI  
Date Received05/03/1994
Decision Date 06/22/1994
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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