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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 K914205
Device Name PFF-1
Applicant
CYBERMEDIC, INC.
C/O MCKENNA & CUNEO LAW OFFICE
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact RICHARD D MANTHEI
Correspondent
CYBERMEDIC, INC.
C/O MCKENNA & CUNEO LAW OFFICE
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Correspondent Contact RICHARD D MANTHEI
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/19/1991
Decision Date 05/01/1992
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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