DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES— 510(k) K051635

Name: FDA 510(k) clearance K051635
Creator: U.S. Food and Drug Administration
Published: 2005-07-15

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K051635 for DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES, Substantially Equivalent on 2005-07-15. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code KOI
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 2005-06-20
Decision date: 2005-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K051635

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 K051635.

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