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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 Plz. Rd.
Greenvale,  NY  11548
Applicant Contact MARDIN VARELA
Correspondent
Medical Systems Corp.
One Plz. Rd.
Greenvale,  NY  11548
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
Predetermined Change
Control Plan Authorized		 No
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