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FDA 510(k)

UBM PLUS, MODEL P45

K-Number: K003141 · 2000-12-05

ApplicantParadigm Medical Industries, Inc.
Decision Date2000-12-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UBM PLUS, MODEL P45 is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Medical Industries, Inc.. It received FDA 510(k) clearance on 2000-12-05 under 510(k) number K003141. 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 UBM PLUS, MODEL P45?

UBM PLUS, MODEL P45 is a medical device that received FDA 510(k) clearance on 2000-12-05. The listed applicant is Paradigm Medical Industries, Inc.. The 510(k) number is K003141.

When did UBM PLUS, MODEL P45 receive FDA 510(k) clearance?

UBM PLUS, MODEL P45 received FDA 510(k) clearance on 2000-12-05, under 510(k) number K003141.

Who is the listed applicant for UBM PLUS, MODEL P45?

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

What is the FDA product code for UBM PLUS, MODEL P45?

The FDA product code for UBM PLUS, MODEL P45 is 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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