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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, apnea, facility use
510(k) Number K822077
Device Name RESPIRATION MONITOR TYPE MR-10
Applicant
NEW DIMENSIONS IN MEDICINE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NEW DIMENSIONS IN MEDICINE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2377
Classification Product Code
FLS  
Date Received07/15/1982
Decision Date 10/06/1982
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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