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FDA 510(k)

RADIOSYSTEM/NT, MODEL 80-13020

K-Number: K020320 · 2002-08-28

ApplicantStyker Instruments
Decision Date2002-08-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOSYSTEM/NT, MODEL 80-13020 is the device name listed in this FDA 510(k) record. The listed applicant is Styker Instruments. It received FDA 510(k) clearance on 2002-08-28 under 510(k) number K020320. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOSYSTEM/NT, MODEL 80-13020?

RADIOSYSTEM/NT, MODEL 80-13020 is a medical device that received FDA 510(k) clearance on 2002-08-28. The listed applicant is Styker Instruments. The 510(k) number is K020320.

When did RADIOSYSTEM/NT, MODEL 80-13020 receive FDA 510(k) clearance?

RADIOSYSTEM/NT, MODEL 80-13020 received FDA 510(k) clearance on 2002-08-28, under 510(k) number K020320.

Who is the listed applicant for RADIOSYSTEM/NT, MODEL 80-13020?

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

What is the FDA product code for RADIOSYSTEM/NT, MODEL 80-13020?

The FDA product code for RADIOSYSTEM/NT, MODEL 80-13020 is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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