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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 K852515
Device Name ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR
Applicant
Alternative Design Systems, Inc.
419 Hackensack Ave.
Carlstadt,  NJ  07072
Applicant Contact JOHN L ESSMYER
Correspondent
Alternative Design Systems, Inc.
419 Hackensack Ave.
Carlstadt,  NJ  07072
Correspondent Contact JOHN L ESSMYER
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received06/13/1985
Decision Date 06/24/1985
Decision Substantially Equivalent (SESE)
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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