AS 191 ECG TELEMETRY MODULE

Electrocardiograph

NARCO SCIENTIFIC

The following data is part of a premarket notification filed by Narco Scientific with the FDA for As 191 Ecg Telemetry Module.

Pre-market Notification Details

Device IDK831429
510k NumberK831429
Device Name:AS 191 ECG TELEMETRY MODULE
ClassificationElectrocardiograph
Applicant NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-03
Decision Date1983-10-14

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