HEART-ALERT

Platform, Force-measuring

MEDICAL EQUIPMENT DEVICES, INC.

The following data is part of a premarket notification filed by Medical Equipment Devices, Inc. with the FDA for Heart-alert.

Pre-market Notification Details

Device IDK820444
510k NumberK820444
Device Name:HEART-ALERT
ClassificationPlatform, Force-measuring
Applicant MEDICAL EQUIPMENT DEVICES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHX  
CFR Regulation Number890.1575 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-18
Decision Date1982-03-12

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