FDA 510(k)

WAVE GATE

K-Number: K853412 · 1985-10-28

Decision Date1985-10-28

Product CodeGWE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

WAVE GATE is the device name listed in this FDA 510(k) record. The listed applicant is Wolfline Corp.. It received FDA 510(k) clearance on 1985-10-28 under 510(k) number K853412. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVE GATE?

WAVE GATE is a medical device that received FDA 510(k) clearance on 1985-10-28. The listed applicant is Wolfline Corp.. The 510(k) number is K853412.

When did WAVE GATE receive FDA 510(k) clearance?

WAVE GATE received FDA 510(k) clearance on 1985-10-28, under 510(k) number K853412.

Who is the listed applicant for WAVE GATE?

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

What is the FDA product code for WAVE GATE?

The FDA product code for WAVE GATE is GWE.

Related Devices (Code: GWE)

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.

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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.