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FDA 510(k)

WAVES

K-Number: K111521 · 2012-02-16

ApplicantWaters Medical Systems, LLC
Decision Date2012-02-16
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WAVES is the device name listed in this FDA 510(k) record. The listed applicant is Waters Medical Systems, LLC. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K111521. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVES?

WAVES is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Waters Medical Systems, LLC. The 510(k) number is K111521.

When did WAVES receive FDA 510(k) clearance?

WAVES received FDA 510(k) clearance on 2012-02-16, under 510(k) number K111521.

Who is the listed applicant for WAVES?

The FDA 510(k) record lists Waters Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVES?

The FDA product code for WAVES is KDN.

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Other records listing Waters Medical Systems, LLC as applicant

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.

K121736PERF-GEN PULSATILE PERFUSION SOLUTIONK121618BEL-GEN COLD STORAGE SOLUTION

Related Devices (Code: KDN)

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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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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