AS/3 NMT MODULE— 510(k) K955026

Name: FDA 510(k) clearance K955026
Creator: U.S. Food and Drug Administration
Published: 1997-04-28

Substantially Equivalent

Datex Medical Instrumentation, Inc.

FDA 510(k) clearance K955026 for AS/3 NMT MODULE, Substantially Equivalent on 1997-04-28. Applicant: Datex Medical Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Datex Medical Instrumentation, Inc.
Product code: Code KOI
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1995-11-02
Decision date: 1997-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksbury, MA, US

Download summary PDF View on FDA.gov ↗

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K961063 — AS/3 CARDIAC OUTPUT & SVO2 MODULE1996-05-31
K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV1996-05-03
K953006 — AS/3 NETWORK LINK1995-09-27
K912530 — CARDIOCAP II(TM)1991-09-05

Recalls naming K955026

K-number listed on FDA's recall record

Z-1640-2014 — GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.Class II·Terminated·GE Healthcare, LLC·20140409

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955026.

Data sourced from openFDA. This site is unofficial and independent of the FDA.