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FDA 510(k)

TOF-GUARD TRANSMISSION MONITOR

K-Number: K925159 · 1993-09-01

ApplicantBiometer Intl. A/S
Decision Date1993-09-01
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TOF-GUARD TRANSMISSION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Biometer Intl. A/S. It received FDA 510(k) clearance on 1993-09-01 under 510(k) number K925159. 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 TOF-GUARD TRANSMISSION MONITOR?

TOF-GUARD TRANSMISSION MONITOR is a medical device that received FDA 510(k) clearance on 1993-09-01. The listed applicant is Biometer Intl. A/S. The 510(k) number is K925159.

When did TOF-GUARD TRANSMISSION MONITOR receive FDA 510(k) clearance?

TOF-GUARD TRANSMISSION MONITOR received FDA 510(k) clearance on 1993-09-01, under 510(k) number K925159.

Who is the listed applicant for TOF-GUARD TRANSMISSION MONITOR?

The FDA 510(k) record lists Biometer Intl. A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOF-GUARD TRANSMISSION MONITOR?

The FDA product code for TOF-GUARD TRANSMISSION MONITOR is KOI.

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Other records listing Biometer Intl. A/S 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.

K914231ELPHA 2000K892396MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITORK893485ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITORK890746MYOTEST DBS NERVE STIMULATORK881196AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNALK870619ACCELOGRAPH

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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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