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FDA 510(k)

CLARITY SYSTEM II

K-Number: K952080 · 1995-09-19

ApplicantSonamed Corp.
Decision Date1995-09-19
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CLARITY SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Sonamed Corp.. It received FDA 510(k) clearance on 1995-09-19 under 510(k) number K952080. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARITY SYSTEM II?

CLARITY SYSTEM II is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Sonamed Corp.. The 510(k) number is K952080.

When did CLARITY SYSTEM II receive FDA 510(k) clearance?

CLARITY SYSTEM II received FDA 510(k) clearance on 1995-09-19, under 510(k) number K952080.

Who is the listed applicant for CLARITY SYSTEM II?

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

What is the FDA product code for CLARITY SYSTEM II?

The FDA product code for CLARITY SYSTEM II is GWJ.

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Related Devices (Code: GWJ)

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.

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