FDA 510(k)

DYONICS CONTROL RF SYSTEM

K-Number: K003572 · 2001-02-15

Decision Date2001-02-15

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DYONICS CONTROL RF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K003572. 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 DYONICS CONTROL RF SYSTEM?

DYONICS CONTROL RF SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K003572.

When did DYONICS CONTROL RF SYSTEM receive FDA 510(k) clearance?

DYONICS CONTROL RF SYSTEM received FDA 510(k) clearance on 2001-02-15, under 510(k) number K003572.

Who is the listed applicant for DYONICS CONTROL RF SYSTEM?

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

What is the FDA product code for DYONICS CONTROL RF SYSTEM?

The FDA product code for DYONICS CONTROL RF SYSTEM is HRX.

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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.