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510(k) Premarket Notification

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Device Classification Name monitor, breathing frequency
510(k) NumberK852515
Device NameACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR
Applicant
ALTERNATIVE DESIGN SYSTEMS, INC.
419 hackensack ave.
carlstadt,  NJ  07072
Contactjohn l essmyer
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received06/13/1985
Decision Date 06/24/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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