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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K942938
Device Name CROSSVENT-4 VENTILATOR
Applicant
Bio-Med Devices, Inc.
1445 Boston Post Rd.
Guilford,  CT  06437
Applicant Contact DEAN J BENNETT, III
Correspondent
Bio-Med Devices, Inc.
1445 Boston Post Rd.
Guilford,  CT  06437
Correspondent Contact DEAN J BENNETT, III
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/22/1994
Decision Date 09/19/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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