QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB

Electrocardiograph

PULSE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Pulse Biomedical, Inc. with the FDA for Qrs Card S-t Segment Analysis Patient Monitoring System Model: Qrs Card Usb.

Pre-market Notification Details

Device IDK100813
510k NumberK100813
Device Name:QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
ClassificationElectrocardiograph
Applicant PULSE BIOMEDICAL, INC. 1305 CATFISH LANE Norristown,  PA  19403
ContactSaleem Hasan
CorrespondentSaleem Hasan
PULSE BIOMEDICAL, INC. 1305 CATFISH LANE Norristown,  PA  19403
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-23
Decision Date2010-07-23
Summary:summary

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