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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, non-life-supporting
510(k) Number K031896
Device Name NASAL-AIR CRITICAL CARE
Applicant
INNOMED TECHNOLOGIES
506 GARDEN STREET
GREENSBURG,  PA  15601
Applicant Contact FRANK PELC
Correspondent
INNOMED TECHNOLOGIES
506 GARDEN STREET
GREENSBURG,  PA  15601
Correspondent Contact FRANK PELC
Regulation Number868.5895
Classification Product Code
MNS  
Subsequent Product Code
BZD  
Date Received06/19/2003
Decision Date 01/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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