CABINET FOR MULTIPLE FUNCTION BLOCKS

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

ELECTRONICS FOR MEDICINE, INC.

The following data is part of a premarket notification filed by Electronics For Medicine, Inc. with the FDA for Cabinet For Multiple Function Blocks.

Pre-market Notification Details

Device IDK830795
510k NumberK830795
Device Name:CABINET FOR MULTIPLE FUNCTION BLOCKS
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant ELECTRONICS FOR MEDICINE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-14
Decision Date1983-05-18

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