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FDA 510(k)

LEKSELL SURGIPLAN, MODEL 1006947

K-Number: K080250 · 2008-05-13

ApplicantElekta Instrument AB
Decision Date2008-05-13
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEKSELL SURGIPLAN, MODEL 1006947 is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K080250. 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 LEKSELL SURGIPLAN, MODEL 1006947?

LEKSELL SURGIPLAN, MODEL 1006947 is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Elekta Instrument AB. The 510(k) number is K080250.

When did LEKSELL SURGIPLAN, MODEL 1006947 receive FDA 510(k) clearance?

LEKSELL SURGIPLAN, MODEL 1006947 received FDA 510(k) clearance on 2008-05-13, under 510(k) number K080250.

Who is the listed applicant for LEKSELL SURGIPLAN, MODEL 1006947?

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

What is the FDA product code for LEKSELL SURGIPLAN, MODEL 1006947?

The FDA product code for LEKSELL SURGIPLAN, MODEL 1006947 is HAW.

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Other records listing Elekta Instrument AB as applicant

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Related Devices (Code: 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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