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FDA 510(k)

VOYAGER 6.0 SOFTWARE OPTION

K-Number: K000310 · 2000-02-15

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2000-02-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VOYAGER 6.0 SOFTWARE OPTION 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 2000-02-15 under 510(k) number K000310. 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 VOYAGER 6.0 SOFTWARE OPTION?

VOYAGER 6.0 SOFTWARE OPTION is a medical device that received FDA 510(k) clearance on 2000-02-15. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K000310.

When did VOYAGER 6.0 SOFTWARE OPTION receive FDA 510(k) clearance?

VOYAGER 6.0 SOFTWARE OPTION received FDA 510(k) clearance on 2000-02-15, under 510(k) number K000310.

Who is the listed applicant for VOYAGER 6.0 SOFTWARE OPTION?

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 VOYAGER 6.0 SOFTWARE OPTION?

The FDA product code for VOYAGER 6.0 SOFTWARE OPTION 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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