THE PORTABLE ANSISCOPE

Electrocardiograph

DYANSYS, INC.

The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for The Portable Ansiscope.

Pre-market Notification Details

Device IDK071168
510k NumberK071168
Device Name:THE PORTABLE ANSISCOPE
ClassificationElectrocardiograph
Applicant DYANSYS, INC. 8 SNOWBERRY COURT Orinda,  CA  94563
ContactMichael A Daniel
CorrespondentMichael A Daniel
DYANSYS, INC. 8 SNOWBERRY COURT Orinda,  CA  94563
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-27
Decision Date2007-08-31
Summary:summary

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