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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K895375
Device Name MULTISPIRO
Applicant
MEDICAL EQUIPMENT DESIGNS, INC.
23461 RIDGE ROUTE DR., SUITE F
LAGUNA HILLS,  CA  92653
Applicant Contact RICHARD ROSENTHAL
Correspondent
MEDICAL EQUIPMENT DESIGNS, INC.
23461 RIDGE ROUTE DR., SUITE F
LAGUNA HILLS,  CA  92653
Correspondent Contact RICHARD ROSENTHAL
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/30/1989
Decision Date 11/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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