510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830325Substantially Equivalent

Tiger Pulse

Bertone & Assoc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830325 is the FDA 510(k) clearance record for TIGER PULSE, a class II device, cleared for Bertone & Assoc. on under FDA product code GZK (Electrode, Nasopharyngeal). FDA records list one 510(k) clearance for Bertone & Assoc. As of , FDA records show no recalls naming K830325.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GZK Electrode, Nasopharyngeal
Regulation
21 CFR 882.1340
Device class
Class II
Review panel
Neurology
Applicant
Bertone & Assoc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GZK

Trailing 12 months

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

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