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FDA 510(k)

POWER DRIVE

K-Number: K012944 · 2001-11-20

ApplicantMediteam AB
Decision Date2001-11-20
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POWER DRIVE is the device name listed in this FDA 510(k) record. The listed applicant is Mediteam AB. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K012944. 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 POWER DRIVE?

POWER DRIVE is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Mediteam AB. The 510(k) number is K012944.

When did POWER DRIVE receive FDA 510(k) clearance?

POWER DRIVE received FDA 510(k) clearance on 2001-11-20, under 510(k) number K012944.

Who is the listed applicant for POWER DRIVE?

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

What is the FDA product code for POWER DRIVE?

The FDA product code for POWER DRIVE is EKX.

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Related Devices (Code: EKX)

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

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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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