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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 K810174
Device Name RESPIRATION FUNCTION BLOCKS
Applicant
HONEYWELL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HONEYWELL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received01/22/1981
Decision Date 03/17/1981
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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