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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, nasal, oxygen
510(k) Number K833351
Device Name DEMAND OXYGEN CONTROLLER
Applicant
HEALTHDYNE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HEALTHDYNE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5350
Classification Product Code
BZB  
Date Received09/28/1983
Decision Date 03/19/1984
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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