510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912938Substantially Equivalent

Rhythm

Stellate Systems, Westmount, Quebec, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912938 is the FDA 510(k) clearance record for RHYTHM, a class I device, cleared for Stellate Systems on under FDA product code GWS (Analyzer, Spectrum, Electroencephalogram Signal). FDA records list 7 510(k) clearances for Stellate Systems, from to . As of , FDA records show no recalls naming K912938.

Clearance record

Decision date
Received
(25 days to decision)
Product code
GWS Analyzer, Spectrum, Electroencephalogram Signal
Regulation
21 CFR 882.1420
Device class
Class I
Review panel
Neurology
Applicant
Stellate Systems 345 Victoria Ave., Suite 300, Westmount, Quebec, CA
510(k) summary
Statement
Third party review
No

Clearances, product code GWS

Trailing 12 months

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

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