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FDA 510(k)

BRAINSCAN WORKSTATION

K-Number: K915819 · 1992-05-11

ApplicantBrainlab Medizinische Computersysteme GmbH
Decision Date1992-05-11
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINSCAN WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab Medizinische Computersysteme GmbH. It received FDA 510(k) clearance on 1992-05-11 under 510(k) number K915819. 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 BRAINSCAN WORKSTATION?

BRAINSCAN WORKSTATION is a medical device that received FDA 510(k) clearance on 1992-05-11. The listed applicant is Brainlab Medizinische Computersysteme GmbH. The 510(k) number is K915819.

When did BRAINSCAN WORKSTATION receive FDA 510(k) clearance?

BRAINSCAN WORKSTATION received FDA 510(k) clearance on 1992-05-11, under 510(k) number K915819.

Who is the listed applicant for BRAINSCAN WORKSTATION?

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

What is the FDA product code for BRAINSCAN WORKSTATION?

The FDA product code for BRAINSCAN WORKSTATION is HAW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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