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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 K810175
Device Name NEO NATAL RESPIRATION FUNCTION BLOCK
Applicant
HONEYWELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HONEYWELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received01/22/1981
Decision Date 03/20/1981
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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