BIO-PROBE SYSTEM-BLOOD FLOW PROBE

Probe, Blood-flow, Extravascular

BIO MEDICUS, INC.

The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-probe System-blood Flow Probe.

Pre-market Notification Details

Device IDK830858
510k NumberK830858
Device Name:BIO-PROBE SYSTEM-BLOOD FLOW PROBE
ClassificationProbe, Blood-flow, Extravascular
Applicant BIO MEDICUS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPT  
CFR Regulation Number870.2120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-17
Decision Date1983-06-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10681490408667 K830858 000
20673978563330 K830858 000
20721902987780 K830858 000
20885074495747 K830858 000

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