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FDA 510(k)

EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS

K-Number: K954646 · 1996-01-18

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1996-01-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS 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 1996-01-18 under 510(k) number K954646. 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 EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS?

EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS is a medical device that received FDA 510(k) clearance on 1996-01-18. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K954646.

When did EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS receive FDA 510(k) clearance?

EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS received FDA 510(k) clearance on 1996-01-18, under 510(k) number K954646.

Who is the listed applicant for EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS?

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 EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS?

The FDA product code for EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS 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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