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FDA 510(k)

RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4

K-Number: K971489 · 1997-07-03

Decision Date1997-07-03
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 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 1997-07-03 under 510(k) number K971489. 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 RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4?

RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K971489.

When did RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 receive FDA 510(k) clearance?

RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971489.

Who is the listed applicant for RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4?

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 RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4?

The FDA product code for RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 is IZI.

Related Clinical Trials

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.

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.

View all 71 devices →

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.

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.

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