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FDA 510(k)

ELEKTA MICRODRIVE, MODEL 916716

K-Number: K040979 · 2004-07-23

ApplicantElekta Instrument AB
Decision Date2004-07-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELEKTA MICRODRIVE, MODEL 916716 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 2004-07-23 under 510(k) number K040979. 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 MICRODRIVE, MODEL 916716?

ELEKTA MICRODRIVE, MODEL 916716 is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Elekta Instrument AB. The 510(k) number is K040979.

When did ELEKTA MICRODRIVE, MODEL 916716 receive FDA 510(k) clearance?

ELEKTA MICRODRIVE, MODEL 916716 received FDA 510(k) clearance on 2004-07-23, under 510(k) number K040979.

Who is the listed applicant for ELEKTA MICRODRIVE, MODEL 916716?

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 MICRODRIVE, MODEL 916716?

The FDA product code for ELEKTA MICRODRIVE, MODEL 916716 is 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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