510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983550Substantially Equivalent

Xyz System

Bio-Monitoring International Corp., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983550 is the FDA 510(k) clearance record for XYZ SYSTEM, a class II device, cleared for Bio-Monitoring International Corp. on under FDA product code HCC (Device, Biofeedback). FDA records list one 510(k) clearance for Bio-Monitoring International Corp. As of , FDA records show no recalls naming K983550.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HCC Device, Biofeedback
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Bio-Monitoring International Corp. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary
Third party review
No

Clearances, product code HCC

Trailing 12 months

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

FDA records show no clearances under product code HCC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCC, 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