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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 K933184
Device Name POSITIVE AIRWAY PRESSURE SYSTEM
Applicant
Innovative Medical Systems, Inc.
1 Merrill Dr.
Hampton,  NH  03842
Applicant Contact FRAN WHITE
Correspondent
Innovative Medical Systems, Inc.
1 Merrill Dr.
Hampton,  NH  03842
Correspondent Contact FRAN WHITE
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/30/1993
Decision Date 11/28/1994
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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