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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 K921513
Device Name SPIROLITE MODEL MSC-201 SPIROMETER
Applicant
MEDICAL SYSTEMS CORP.
ONE PLAZA RD.
GREENVALE,  NY  11548 -9801
Applicant Contact MARDIN VARELA
Correspondent
MEDICAL SYSTEMS CORP.
ONE PLAZA RD.
GREENVALE,  NY  11548 -9801
Correspondent Contact MARDIN VARELA
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/31/1992
Decision Date 01/27/1993
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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