OSC-80 OXIMETER

Oximeter

WATERS INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Osc-80 Oximeter.

Pre-market Notification Details

Device IDK862161
510k NumberK862161
Device Name:OSC-80 OXIMETER
ClassificationOximeter
Applicant WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester,  MN  55903 -6117
ContactLewis N Harrold
CorrespondentLewis N Harrold
WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester,  MN  55903 -6117
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-06
Decision Date1986-08-18

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