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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K971229
Device Name CAPNOXYGEN MASK
Applicant
MEDSYS, INC.
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
MEDSYS, INC.
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/02/1997
Decision Date 09/23/1997
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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