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FDA 510(k)

O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100

K-Number: K981724 · 1998-06-22

ApplicantMedtrex, Inc.
Decision Date1998-06-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 is the device name listed in this FDA 510(k) record. The listed applicant is Medtrex, Inc.. It received FDA 510(k) clearance on 1998-06-22 under 510(k) number K981724. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100?

O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 is a medical device that received FDA 510(k) clearance on 1998-06-22. The listed applicant is Medtrex, Inc.. The 510(k) number is K981724.

When did O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 receive FDA 510(k) clearance?

O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 received FDA 510(k) clearance on 1998-06-22, under 510(k) number K981724.

Who is the listed applicant for O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100?

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

What is the FDA product code for O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100?

The FDA product code for O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 is GEI.

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Other records listing Medtrex, Inc. as applicant

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Official Source

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