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FDA 510(k)

POWERDRIVE 350 OPTION

K-Number: K002415 · 2000-08-18

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2000-08-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POWERDRIVE 350 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 2000-08-18 under 510(k) number K002415. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERDRIVE 350 OPTION?

POWERDRIVE 350 OPTION is a medical device that received FDA 510(k) clearance on 2000-08-18. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K002415.

When did POWERDRIVE 350 OPTION receive FDA 510(k) clearance?

POWERDRIVE 350 OPTION received FDA 510(k) clearance on 2000-08-18, under 510(k) number K002415.

Who is the listed applicant for POWERDRIVE 350 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 POWERDRIVE 350 OPTION?

The FDA product code for POWERDRIVE 350 OPTION is LNH.

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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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