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FDA 510(k)

MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)

K-Number: K970965 · 1997-04-09

ApplicantMidas Rex Pneumatic Tools, Inc.
Decision Date1997-04-09
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) is the device name listed in this FDA 510(k) record. The listed applicant is Midas Rex Pneumatic Tools, Inc.. It received FDA 510(k) clearance on 1997-04-09 under 510(k) number K970965. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)?

MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) is a medical device that received FDA 510(k) clearance on 1997-04-09. The listed applicant is Midas Rex Pneumatic Tools, Inc.. The 510(k) number is K970965.

When did MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) receive FDA 510(k) clearance?

MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) received FDA 510(k) clearance on 1997-04-09, under 510(k) number K970965.

Who is the listed applicant for MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)?

The FDA 510(k) record lists Midas Rex Pneumatic Tools, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)?

The FDA product code for MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) is ERL.

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Other records listing Midas Rex Pneumatic Tools, 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.

K972289MIDAS REX MOTORK962483MIDAS REX III MOTORK953434MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)K954076MIDAS REX DRILL ATTACHMENTS & TWIST DRILLSK953433MIDAS REX TELESCOPING SYSTEMK953432ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS

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Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker 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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