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FDA 510(k)

NUWAV

K-Number: K081781 · 2008-07-09

ApplicantLaborie Medical Technologies, Corp.
Decision Date2008-07-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NUWAV is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2008-07-09 under 510(k) number K081781. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUWAV?

NUWAV is a medical device that received FDA 510(k) clearance on 2008-07-09. The listed applicant is Laborie Medical Technologies, Corp.. The 510(k) number is K081781.

When did NUWAV receive FDA 510(k) clearance?

NUWAV received FDA 510(k) clearance on 2008-07-09, under 510(k) number K081781.

Who is the listed applicant for NUWAV?

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

What is the FDA product code for NUWAV?

The FDA product code for NUWAV is IYO.

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Other records listing Laborie Medical Technologies, Corp. as applicant

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Related Devices (Code: IYO)

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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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