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FDA 510(k)

LINA POWERBLADE PLUS

K-Number: K132837 · 2013-12-19

ApplicantLina Medical Aps
Decision Date2013-12-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LINA POWERBLADE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2013-12-19 under 510(k) number K132837. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINA POWERBLADE PLUS?

LINA POWERBLADE PLUS is a medical device that received FDA 510(k) clearance on 2013-12-19. The listed applicant is Lina Medical Aps. The 510(k) number is K132837.

When did LINA POWERBLADE PLUS receive FDA 510(k) clearance?

LINA POWERBLADE PLUS received FDA 510(k) clearance on 2013-12-19, under 510(k) number K132837.

Who is the listed applicant for LINA POWERBLADE PLUS?

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

What is the FDA product code for LINA POWERBLADE PLUS?

The FDA product code for LINA POWERBLADE PLUS is GEI.

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Related Devices (Code: GEI)

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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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