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FDA 510(k)

DIZZYFIX

K-Number: K081602 · 2008-09-19

ApplicantClearwater Clinical Limited
Decision Date2008-09-19
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

DIZZYFIX is the device name listed in this FDA 510(k) record. The listed applicant is Clearwater Clinical Limited. It received FDA 510(k) clearance on 2008-09-19 under 510(k) number K081602. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIZZYFIX?

DIZZYFIX is a medical device that received FDA 510(k) clearance on 2008-09-19. The listed applicant is Clearwater Clinical Limited. The 510(k) number is K081602.

When did DIZZYFIX receive FDA 510(k) clearance?

DIZZYFIX received FDA 510(k) clearance on 2008-09-19, under 510(k) number K081602.

Who is the listed applicant for DIZZYFIX?

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

What is the FDA product code for DIZZYFIX?

The FDA product code for DIZZYFIX is LXV.

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Related Devices (Code: LXV)

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Official Source

View on FDA Database →

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

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