FDA 510(k)

ECHO PLANAR IMAGING I

K-Number: K945828 · 1995-04-12

ApplicantPhilips Medical Systems (Cleveland), Inc.

Decision Date1995-04-12

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ECHO PLANAR IMAGING I 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 1995-04-12 under 510(k) number K945828. 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 ECHO PLANAR IMAGING I?

ECHO PLANAR IMAGING I is a medical device that received FDA 510(k) clearance on 1995-04-12. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K945828.

When did ECHO PLANAR IMAGING I receive FDA 510(k) clearance?

ECHO PLANAR IMAGING I received FDA 510(k) clearance on 1995-04-12, under 510(k) number K945828.

Who is the listed applicant for ECHO PLANAR IMAGING I?

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 ECHO PLANAR IMAGING I?

The FDA product code for ECHO PLANAR IMAGING I is LNH.

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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.