510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182214Substantially Equivalent

DizzyDoctor System 1.0.0

Dizzydoctor Systems, LLC, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182214 is the FDA 510(k) clearance record for DizzyDoctor System 1.0.0, a class II device, cleared for Dizzydoctor Systems, LLC on under FDA product code GWN (Nystagmograph). FDA records list one 510(k) clearance for Dizzydoctor Systems, LLC. As of , FDA records show no recalls naming K182214.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GWN Nystagmograph
Regulation
21 CFR 882.1460
Device class
Class II
Review panel
Neurology
Applicant
Dizzydoctor Systems, LLC 7625 Mesa College Dr., Suite 200a, San Diego CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GWN

Trailing 12 months
1 clearance under product code GWN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260