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FDA 510(k)

MARK 20 AND MARK 25 HAND ENGINE CONTROLLER

K-Number: K964860 · 1997-03-03

ApplicantBell Intl., Inc.
Decision Date1997-03-03
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MARK 20 AND MARK 25 HAND ENGINE CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Bell Intl., Inc.. It received FDA 510(k) clearance on 1997-03-03 under 510(k) number K964860. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK 20 AND MARK 25 HAND ENGINE CONTROLLER?

MARK 20 AND MARK 25 HAND ENGINE CONTROLLER is a medical device that received FDA 510(k) clearance on 1997-03-03. The listed applicant is Bell Intl., Inc.. The 510(k) number is K964860.

When did MARK 20 AND MARK 25 HAND ENGINE CONTROLLER receive FDA 510(k) clearance?

MARK 20 AND MARK 25 HAND ENGINE CONTROLLER received FDA 510(k) clearance on 1997-03-03, under 510(k) number K964860.

Who is the listed applicant for MARK 20 AND MARK 25 HAND ENGINE CONTROLLER?

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

What is the FDA product code for MARK 20 AND MARK 25 HAND ENGINE CONTROLLER?

The FDA product code for MARK 20 AND MARK 25 HAND ENGINE CONTROLLER is EBW.

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Other records listing Bell Intl., 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.

K964863MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN

Related Devices (Code: EBW)

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.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, 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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