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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Monitor, Breathing Frequency
510(k) Number K924875
Device Name MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
Applicant
Synectics-Dantec
1425 Greenway Dr.
Suite 600
Irving,  TX  75038
Applicant Contact ANNA PETTERSSON
Correspondent
Synectics-Dantec
1425 Greenway Dr.
Suite 600
Irving,  TX  75038
Correspondent Contact ANNA PETTERSSON
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/14/1992
Decision Date 06/30/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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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