FDA 510(k)

POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES

K-Number: K080617 · 2008-06-27

ApplicantRichard Wolf Medical Instruments Corp.

Decision Date2008-06-27

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K080617. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES?

POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K080617.

When did POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES receive FDA 510(k) clearance?

POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES received FDA 510(k) clearance on 2008-06-27, under 510(k) number K080617.

Who is the listed applicant for POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES?

The FDA product code for POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES is HRX.

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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.