510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843004Substantially Equivalent

Servo Med Nystagmograph Ng-1

Servo Med, Inc., Greenwich CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843004 is the FDA 510(k) clearance record for SERVO MED NYSTAGMOGRAPH NG-1, a class II device, cleared for Servo Med, Inc. on under FDA product code GWN (Nystagmograph). FDA records list one 510(k) clearance for Servo Med, Inc. As of , FDA records show no recalls naming K843004.

Clearance record

Decision date
Received
(92 days to decision)
Product code
GWN Nystagmograph
Regulation
21 CFR 882.1460
Device class
Class II
Review panel
Neurology
Applicant
Servo Med, Inc. 600 Steamboat Rd., Greenwich CT
Third party review
No

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