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FDA 510(k)

BRAINSCAN

K-Number: K994413 · 2000-07-13

ApplicantBrainlab AG
Decision Date2000-07-13
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAINSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2000-07-13 under 510(k) number K994413. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINSCAN?

BRAINSCAN is a medical device that received FDA 510(k) clearance on 2000-07-13. The listed applicant is Brainlab AG. The 510(k) number is K994413.

When did BRAINSCAN receive FDA 510(k) clearance?

BRAINSCAN received FDA 510(k) clearance on 2000-07-13, under 510(k) number K994413.

Who is the listed applicant for BRAINSCAN?

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

What is the FDA product code for BRAINSCAN?

The FDA product code for BRAINSCAN is MUJ.

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Other records listing Brainlab AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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