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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, helium, gaseous-phase
510(k) Number K841858
Device Name SPIROLOOP
Applicant
DATAMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DATAMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1640
Classification Product Code
BSE  
Date Received05/04/1984
Decision Date 07/11/1984
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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