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FDA 510(k)

ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT

K-Number: K031999 · 2003-07-25

ApplicantElekta Instrument AB
Decision Date2003-07-25
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT 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 2003-07-25 under 510(k) number K031999. 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 ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT?

ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is Elekta Instrument AB. The 510(k) number is K031999.

When did ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT receive FDA 510(k) clearance?

ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT received FDA 510(k) clearance on 2003-07-25, under 510(k) number K031999.

Who is the listed applicant for ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT?

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 ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT?

The FDA product code for ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT 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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