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FDA 510(k)

OUTLOOK

K-Number: K945827 · 1995-09-18

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1995-09-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OUTLOOK 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 1995-09-18 under 510(k) number K945827. 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 OUTLOOK?

OUTLOOK is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K945827.

When did OUTLOOK receive FDA 510(k) clearance?

OUTLOOK received FDA 510(k) clearance on 1995-09-18, under 510(k) number K945827.

Who is the listed applicant for OUTLOOK?

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 OUTLOOK?

The FDA product code for OUTLOOK 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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