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FDA 510(k)

INFINION ENHANCEMENT PACKAGE

K-Number: K011296 · 2001-07-19

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2001-07-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINION ENHANCEMENT PACKAGE 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 2001-07-19 under 510(k) number K011296. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINION ENHANCEMENT PACKAGE?

INFINION ENHANCEMENT PACKAGE is a medical device that received FDA 510(k) clearance on 2001-07-19. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K011296.

When did INFINION ENHANCEMENT PACKAGE receive FDA 510(k) clearance?

INFINION ENHANCEMENT PACKAGE received FDA 510(k) clearance on 2001-07-19, under 510(k) number K011296.

Who is the listed applicant for INFINION ENHANCEMENT PACKAGE?

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 INFINION ENHANCEMENT PACKAGE?

The FDA product code for INFINION ENHANCEMENT PACKAGE is LNH.

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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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