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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 K872833
Device Name BREATHGUARD APNEA MONITOR
Applicant
Lada Intl., Inc.
521 W. Golf Rd.
Arlington Heights,  IL  60005
Applicant Contact DAVID M NEUPERT
Correspondent
Lada Intl., Inc.
521 W. Golf Rd.
Arlington Heights,  IL  60005
Correspondent Contact DAVID M NEUPERT
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/17/1987
Decision Date 04/01/1988
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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