510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091963Substantially Equivalent

Vigilant EEG Monitor, Vigilant 2.0

Infinite Biomedical Technologies, LLC, Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091963 is the FDA 510(k) clearance record for VIGILANT EEG MONITOR, VIGILANT 2.0, a class II device, cleared for Infinite Biomedical Technologies, LLC on under FDA product code OLT (Non-Normalizing Quantitative Electroencephalograph Software). FDA's definition for product code OLT reads: "Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user". FDA records list 6 510(k) clearances for Infinite Biomedical Technologies, LLC, from to . As of , FDA records show no recalls naming K091963.

Clearance record

Decision date
Received
(128 days to decision)
Product code
OLT Non-Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Infinite Biomedical Technologies, LLC 3600 Clipper Mill Rd., Baltimore MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLT

Trailing 12 months
4 clearances under product code OLT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20261
October 20260