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FDA 510(k)

EP NAVIGATOR SOFTWARE

K-Number: K062650 · 2006-09-21

ApplicantPhilips Medical Systems
Decision Date2006-09-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EP NAVIGATOR SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2006-09-21 under 510(k) number K062650. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EP NAVIGATOR SOFTWARE?

EP NAVIGATOR SOFTWARE is a medical device that received FDA 510(k) clearance on 2006-09-21. The listed applicant is Philips Medical Systems. The 510(k) number is K062650.

When did EP NAVIGATOR SOFTWARE receive FDA 510(k) clearance?

EP NAVIGATOR SOFTWARE received FDA 510(k) clearance on 2006-09-21, under 510(k) number K062650.

Who is the listed applicant for EP NAVIGATOR SOFTWARE?

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

What is the FDA product code for EP NAVIGATOR SOFTWARE?

The FDA product code for EP NAVIGATOR SOFTWARE is LLZ.

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Other records listing Philips Medical Systems 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: LLZ)

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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