MONITORING SYSTEM, REHABILITATION

Electrocardiograph

MEDCRAFT CORP.

The following data is part of a premarket notification filed by Medcraft Corp. with the FDA for Monitoring System, Rehabilitation.

Pre-market Notification Details

Device IDK760510
510k NumberK760510
Device Name:MONITORING SYSTEM, REHABILITATION
ClassificationElectrocardiograph
Applicant MEDCRAFT CORP. 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 Received1976-08-24
Decision Date1976-08-30

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