AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202

System, Measurement, Blood-pressure, Non-invasive

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Ambulatory Blood Pressure Monitor Spacelabs #90202.

Pre-market Notification Details

Device IDK855127
510k NumberK855127
Device Name:AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
ContactHans, P.e.
CorrespondentHans, P.e.
SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-23
Decision Date1986-08-14

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