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FDA 510(k)

POWERTOME PERIOTOME

K-Number: K063007 · 2006-10-17

ApplicantWestport Medical, Inc.
Decision Date2006-10-17
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POWERTOME PERIOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Westport Medical, Inc.. It received FDA 510(k) clearance on 2006-10-17 under 510(k) number K063007. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERTOME PERIOTOME?

POWERTOME PERIOTOME is a medical device that received FDA 510(k) clearance on 2006-10-17. The listed applicant is Westport Medical, Inc.. The 510(k) number is K063007.

When did POWERTOME PERIOTOME receive FDA 510(k) clearance?

POWERTOME PERIOTOME received FDA 510(k) clearance on 2006-10-17, under 510(k) number K063007.

Who is the listed applicant for POWERTOME PERIOTOME?

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

What is the FDA product code for POWERTOME PERIOTOME?

The FDA product code for POWERTOME PERIOTOME is EKX.

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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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