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FDA 510(k)

MEB-5200

K-Number: K854664 · 1986-08-14

ApplicantNihon Kohden America, Inc.
Decision Date1986-08-14
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MEB-5200 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1986-08-14 under 510(k) number K854664. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEB-5200?

MEB-5200 is a medical device that received FDA 510(k) clearance on 1986-08-14. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K854664.

When did MEB-5200 receive FDA 510(k) clearance?

MEB-5200 received FDA 510(k) clearance on 1986-08-14, under 510(k) number K854664.

Who is the listed applicant for MEB-5200?

The FDA 510(k) record lists Nihon Kohden America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEB-5200?

The FDA product code for MEB-5200 is IKT.

Other records listing Nihon Kohden America, 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.

K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXK120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PK092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMK083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PK083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYK082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

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Related Devices (Code: IKT)

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.

K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)Technomed EuropeK173815Allergan Botox Needle ElectrodeNatus Manufacturing LimitedK161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing LimitedK152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLCK112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.

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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