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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 K854355
Device Name GREENLEAF SMART POLYGRAPH PROGRAM
Applicant
GREENLEAF SCIENCE CORP.
644 EMERSON ST.
PALO ALTO,  CA  94301
Applicant Contact WALTER GREENLEAF
Correspondent
GREENLEAF SCIENCE CORP.
644 EMERSON ST.
PALO ALTO,  CA  94301
Correspondent Contact WALTER GREENLEAF
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received10/29/1985
Decision Date 04/18/1986
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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