HP CATHSTATION - MODEL M1264B

Electrocardiograph

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Cathstation - Model M1264b.

Pre-market Notification Details

Device IDK961401
510k NumberK961401
Device Name:HP CATHSTATION - MODEL M1264B
ClassificationElectrocardiograph
Applicant HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover,  MA  01810 -1085
ContactRob Butler
CorrespondentRob Butler
HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover,  MA  01810 -1085
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-11
Decision Date1996-10-08
Summary:summary

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