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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K852909
Device Name MVP - 6000
Applicant
WATERS INSTRUMENTS, INC.
2411 SEVENTH ST. N.W.
P.O. BOX 6117
ROCHESTER,  MN  55903 -6117
Applicant Contact JOAN A GOETZ
Correspondent
WATERS INSTRUMENTS, INC.
2411 SEVENTH ST. N.W.
P.O. BOX 6117
ROCHESTER,  MN  55903 -6117
Correspondent Contact JOAN A GOETZ
Regulation Number868.1880
Classification Product Code
BZC  
Date Received07/09/1985
Decision Date 11/14/1985
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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