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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K980443
Device Name PEAK FLOW METER MINIMAX
Applicant
THE D&T, INC.
86 BEDFORD AVE.
HAMDEN,  CT  06517
Applicant Contact GEORGE DEBUSH
Correspondent
THE D&T, INC.
86 BEDFORD AVE.
HAMDEN,  CT  06517
Correspondent Contact GEORGE DEBUSH
Regulation Number868.1860
Classification Product Code
BZH  
Date Received02/05/1998
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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