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FDA 510(k)

ELEKTA STEREOTACTIC GUIDE

K-Number: K991636 · 1999-07-20

ApplicantElekta Instrument AB
Decision Date1999-07-20
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELEKTA STEREOTACTIC GUIDE 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 1999-07-20 under 510(k) number K991636. 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 STEREOTACTIC GUIDE?

ELEKTA STEREOTACTIC GUIDE is a medical device that received FDA 510(k) clearance on 1999-07-20. The listed applicant is Elekta Instrument AB. The 510(k) number is K991636.

When did ELEKTA STEREOTACTIC GUIDE receive FDA 510(k) clearance?

ELEKTA STEREOTACTIC GUIDE received FDA 510(k) clearance on 1999-07-20, under 510(k) number K991636.

Who is the listed applicant for ELEKTA STEREOTACTIC GUIDE?

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 STEREOTACTIC GUIDE?

The FDA product code for ELEKTA STEREOTACTIC GUIDE 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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