510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955026Substantially Equivalent

As/3 Nmt Module

Datex Medical Instrumentation, Inc., Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955026 is the FDA 510(k) clearance record for AS/3 NMT MODULE, a class II device, cleared for Datex Medical Instrumentation, Inc. on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list 5 510(k) clearances for Datex Medical Instrumentation, Inc., from to . As of , FDA records show one recall naming K955026.

Clearance record

Decision date
Received
(543 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex Medical Instrumentation, Inc. 2 Highwood Dr., Tewksbury MA
510(k) summary
Summary
Third party review
No

Clearances, product code KOI

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