VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

BIB, INC.

The following data is part of a premarket notification filed by Bib, Inc. with the FDA for Vita/trac 4 Function Vital Sign Monitor.

Pre-market Notification Details

Device IDK830916
510k NumberK830916
Device Name:VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant BIB, 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 Received1983-03-22
Decision Date1983-07-07

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