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FDA 510(k)

VIEWPOINT - 3.0 SOFTWARE

K-Number: K970604 · 1997-05-19

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1997-05-19
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VIEWPOINT - 3.0 SOFTWARE 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 1997-05-19 under 510(k) number K970604. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIEWPOINT - 3.0 SOFTWARE?

VIEWPOINT - 3.0 SOFTWARE is a medical device that received FDA 510(k) clearance on 1997-05-19. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K970604.

When did VIEWPOINT - 3.0 SOFTWARE receive FDA 510(k) clearance?

VIEWPOINT - 3.0 SOFTWARE received FDA 510(k) clearance on 1997-05-19, under 510(k) number K970604.

Who is the listed applicant for VIEWPOINT - 3.0 SOFTWARE?

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 VIEWPOINT - 3.0 SOFTWARE?

The FDA product code for VIEWPOINT - 3.0 SOFTWARE is HAW.

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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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