ALPHA CARDIAC OUTPUT CARDULE #1899

Computer, Diagnostic, Pre-programmed, Single-function

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Alpha Cardiac Output Cardule #1899.

Pre-market Notification Details

Device IDK832644
510k NumberK832644
Device Name:ALPHA CARDIAC OUTPUT CARDULE #1899
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-05
Decision Date1984-01-27

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