BARO/TRAC II & VITA/TRAC, VITAL SIGN MON

System, Measurement, Blood-pressure, Non-invasive

BIB, INC.

The following data is part of a premarket notification filed by Bib, Inc. with the FDA for Baro/trac Ii & Vita/trac, Vital Sign Mon.

Pre-market Notification Details

Device IDK801389
510k NumberK801389
Device Name:BARO/TRAC II & VITA/TRAC, VITAL SIGN MON
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant BIB, INC. 803 N. Front St. Suite 3 McHenry,  IL  60050
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-13
Decision Date1980-07-28

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