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FDA 510(k)

UNIVERSIX 120

K-Number: K954196 · 1995-10-24

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1995-10-24
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNIVERSIX 120 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1995-10-24 under 510(k) number K954196. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSIX 120?

UNIVERSIX 120 is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K954196.

When did UNIVERSIX 120 receive FDA 510(k) clearance?

UNIVERSIX 120 received FDA 510(k) clearance on 1995-10-24, under 510(k) number K954196.

Who is the listed applicant for UNIVERSIX 120?

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

What is the FDA product code for UNIVERSIX 120?

The FDA product code for UNIVERSIX 120 is KPR.

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Related Devices (Code: KPR)

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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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