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FDA 510(k)

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT

K-Number: K971571 · 1997-07-29

ApplicantWaters Instruments, Inc.
Decision Date1997-07-29
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Waters Instruments, Inc.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K971571. 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 RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT?

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Waters Instruments, Inc.. The 510(k) number is K971571.

When did RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT receive FDA 510(k) clearance?

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT received FDA 510(k) clearance on 1997-07-29, under 510(k) number K971571.

Who is the listed applicant for RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT?

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

What is the FDA product code for RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT?

The FDA product code for RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT is KDN.

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Other records listing Waters Instruments, Inc. 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.

K053169RM3 RENAL PRESERVATION SYSTEMK042224RM3 RENAL PRESERVATION SYSTEMK921519OXICOM-2100K911207OXICOMPLUSK863210VELCOM-100K862161OSC-80 OXIMETER

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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

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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