ARROW-JOHANS ECG ADAPTOR

Catheter, Percutaneous

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow-johans Ecg Adaptor.

Pre-market Notification Details

Device IDK843263
510k NumberK843263
Device Name:ARROW-JOHANS ECG ADAPTOR
ClassificationCatheter, Percutaneous
Applicant ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-20
Decision Date1984-09-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20801902100508 K843263 000
20801902003472 K843263 000

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