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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
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