510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K050702Substantially Equivalent

Neurosystems 1Tm Monitor

Neurosystems, LLC, Woodstock VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050702 is the FDA 510(k) clearance record for NEUROSYSTEMS 1TM MONITOR, a class II device, cleared for Neurosystems, LLC on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list one 510(k) clearance for Neurosystems, LLC. As of , FDA records show no recalls naming K050702.

Clearance record

Decision date
Received
(60 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Neurosystems, LLC 103 Pomfret Rd., Woodstock VT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWM

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