510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152040Substantially Equivalent

X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)

Advanced Brain Monitoring, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152040 is the FDA 510(k) clearance record for X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29), a class II device, cleared for Advanced Brain Monitoring, Inc. on under FDA product code OMC (Reduced- Montage Standard Electroencephalograph). FDA's definition for product code OMC reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes". FDA records list 15 510(k) clearances for Advanced Brain Monitoring, Inc., from to . As of , FDA records show no recalls naming K152040.

Clearance record

Decision date
Received
(100 days to decision)
Product code
OMC Reduced- Montage Standard Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Advanced Brain Monitoring, Inc. 2237 Faraday Ave., Suite 100, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMC

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