510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222680Substantially Equivalent

DeltaScan Monitor

Prolira B.V., Utrecht, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222680 is the FDA 510(k) clearance record for DeltaScan Monitor, a class II device, cleared for Prolira B.V. on under FDA product code NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid). FDA's definition for product code NCG reads: "Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of...". FDA records list 2 510(k) clearances for Prolira B.V. As of , FDA records show no recalls naming K222680.

Clearance record

Decision date
Received
(149 days to decision)
Product code
NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Regulation
21 CFR 882.1440
Device class
Class II
Review panel
Neurology
Applicant
Prolira B.V. Padualaan 8, Utrecht, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NCG

Trailing 12 months
1 clearance under product code NCG 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 NCG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260