FDA 510(k)

IPU RX-2

K-Number: K964327 · 1997-01-17

Decision Date1997-01-17

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IPU RX-2 is the device name listed in this FDA 510(k) record. The listed applicant is Medirex, Inc.. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K964327. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPU RX-2?

IPU RX-2 is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Medirex, Inc.. The 510(k) number is K964327.

When did IPU RX-2 receive FDA 510(k) clearance?

IPU RX-2 received FDA 510(k) clearance on 1997-01-17, under 510(k) number K964327.

Who is the listed applicant for IPU RX-2?

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

What is the FDA product code for IPU RX-2?

The FDA product code for IPU RX-2 is LLZ.

Other records listing Medirex, 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.

K965013DIGISCOPE RX-2 (9 OPTION)K960198DIGISCOPE RX-2

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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.