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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K946322
Device Name POLYGRAM SOFTWARE
Applicant
SYNECTICS MEDICAL, INC.
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM,  SE S-11628
Applicant Contact ANNA PETTERSON
Correspondent
SYNECTICS MEDICAL, INC.
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM,  SE S-11628
Correspondent Contact ANNA PETTERSON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/28/1994
Decision Date 07/07/1995
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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