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FDA 510(k)

PHILIPS INTEGRIS V5000 AND BV5000

K-Number: K973482 · 1997-11-10

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1997-11-10
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS INTEGRIS V5000 AND BV5000 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K973482. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS INTEGRIS V5000 AND BV5000?

PHILIPS INTEGRIS V5000 AND BV5000 is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K973482.

When did PHILIPS INTEGRIS V5000 AND BV5000 receive FDA 510(k) clearance?

PHILIPS INTEGRIS V5000 AND BV5000 received FDA 510(k) clearance on 1997-11-10, under 510(k) number K973482.

Who is the listed applicant for PHILIPS INTEGRIS V5000 AND BV5000?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHILIPS INTEGRIS V5000 AND BV5000?

The FDA product code for PHILIPS INTEGRIS V5000 AND BV5000 is IZI.

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Other records listing Philips Medical Systems North America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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