510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K093949Substantially Equivalent

Olympic Brainz Monitor Model Obm70001

Bio-Logic Systems Corp., Oakville, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K093949 is the FDA 510(k) clearance record for OLYMPIC BRAINZ MONITOR MODEL OBM70001, a class II device, cleared for Natus Medical, Inc. on under FDA product code OMA (Amplitude-Integrated Electroencephalograph). FDA's definition for product code OMA reads: "Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner)". FDA records list 57 510(k) clearances for Bio-Logic Systems Corp., from to . As of , FDA records show no recalls naming K093949.

Clearance record

Decision date
Received
(175 days to decision)
Product code
OMA Amplitude-Integrated Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Natus Medical, Inc. 2568 Bristol Cir., Oakville, CA
510(k) summary
Statement
Third party review
No

Clearances, product code OMA

Trailing 12 months

FDA records hold no clearances under product code OMA in the trailing twelve months.

FDA records show no clearances under product code OMA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260