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FDA 510(k)

ANGIO II

K-Number: K945397 · 1995-02-09

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1995-02-09
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANGIO II 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 1995-02-09 under 510(k) number K945397. 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 ANGIO II?

ANGIO II is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K945397.

When did ANGIO II receive FDA 510(k) clearance?

ANGIO II received FDA 510(k) clearance on 1995-02-09, under 510(k) number K945397.

Who is the listed applicant for ANGIO II?

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 ANGIO II?

The FDA product code for ANGIO II 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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