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FDA 510(k)

AS/3 NMT MODULE

K-Number: K955026 · 1997-04-28

ApplicantDatex Medical Instrumentation, Inc.
Decision Date1997-04-28
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AS/3 NMT MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Datex Medical Instrumentation, Inc.. It received FDA 510(k) clearance on 1997-04-28 under 510(k) number K955026. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS/3 NMT MODULE?

AS/3 NMT MODULE is a medical device that received FDA 510(k) clearance on 1997-04-28. The listed applicant is Datex Medical Instrumentation, Inc.. The 510(k) number is K955026.

When did AS/3 NMT MODULE receive FDA 510(k) clearance?

AS/3 NMT MODULE received FDA 510(k) clearance on 1997-04-28, under 510(k) number K955026.

Who is the listed applicant for AS/3 NMT MODULE?

The FDA 510(k) record lists Datex Medical Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AS/3 NMT MODULE?

The FDA product code for AS/3 NMT MODULE is KOI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Datex Medical Instrumentation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961063AS/3 CARDIAC OUTPUT & SVO2 MODULEK960490AS/3 COMPACT AIRWAY MODULE M-CAIOVK953006AS/3 NETWORK LINKK912530CARDIOCAP II(TM)

Related Devices (Code: KOI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)Senzime ABK250887Neuromuscular Transmission Monitor TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK242525iTOF®Nerbio Medical Software Platforms, Inc.K220530Tetragraph Neuromuscular Transmission MonitorSenzime ABK220976Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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