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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K853433
Device Name ELF
Applicant
CARDIO-RESPIRATORY
JOHNSON, JOHNSON & JOHNSON
1725 ONE DALLAS CENTRE
DALLAS,  TX  75201
Applicant Contact RALPH PERRY-MILLER
Correspondent
CARDIO-RESPIRATORY
JOHNSON, JOHNSON & JOHNSON
1725 ONE DALLAS CENTRE
DALLAS,  TX  75201
Correspondent Contact RALPH PERRY-MILLER
Regulation Number868.1890
Classification Product Code
BTY  
Date Received08/15/1985
Decision Date 11/29/1985
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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