510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220553Substantially Equivalent

Neuro Omega System, NeuroSmart System

Alpha Omega Engineering Ltd., Nof Hagalil (Nazareth Illit), IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220553 is the FDA 510(k) clearance record for Neuro Omega System, NeuroSmart System, a class II device, cleared for Alpha Omega Engineering , Ltd. on under FDA product code GZL (Electrode, Depth). FDA records list 9 510(k) clearances for Alpha Omega Engineering , Ltd., from to . As of , FDA records show no recalls naming K220553.

Clearance record

Decision date
Received
(200 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Alpha Omega Engineering , Ltd. Hamerkava St. 6 Tsiporit Industrial Zone, Nof Hagalil (Nazareth Illit), IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZL

Trailing 12 months
2 clearances under product code GZL 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 GZL, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260