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FDA 510(k)

RENALYZER PRX 90

K-Number: K903034 · 1991-03-13

ApplicantSwedish Trade Council USA
Decision Date1991-03-13
Product CodeCGL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RENALYZER PRX 90 is the device name listed in this FDA 510(k) record. The listed applicant is Swedish Trade Council USA. It received FDA 510(k) clearance on 1991-03-13 under 510(k) number K903034. The device is classified under product code CGL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENALYZER PRX 90?

RENALYZER PRX 90 is a medical device that received FDA 510(k) clearance on 1991-03-13. The listed applicant is Swedish Trade Council USA. The 510(k) number is K903034.

When did RENALYZER PRX 90 receive FDA 510(k) clearance?

RENALYZER PRX 90 received FDA 510(k) clearance on 1991-03-13, under 510(k) number K903034.

Who is the listed applicant for RENALYZER PRX 90?

The FDA 510(k) record lists Swedish Trade Council USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENALYZER PRX 90?

The FDA product code for RENALYZER PRX 90 is CGL.

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Other records listing Swedish Trade Council USA 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.

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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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