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FDA 510(k)

BRAINLAB MASK SYSTEM

K-Number: K945903 · 1995-06-05

ApplicantBrainlab Med. Computersysteme GmbH
Decision Date1995-06-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAINLAB MASK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab Med. Computersysteme GmbH. It received FDA 510(k) clearance on 1995-06-05 under 510(k) number K945903. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINLAB MASK SYSTEM?

BRAINLAB MASK SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Brainlab Med. Computersysteme GmbH. The 510(k) number is K945903.

When did BRAINLAB MASK SYSTEM receive FDA 510(k) clearance?

BRAINLAB MASK SYSTEM received FDA 510(k) clearance on 1995-06-05, under 510(k) number K945903.

Who is the listed applicant for BRAINLAB MASK SYSTEM?

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

What is the FDA product code for BRAINLAB MASK SYSTEM?

The FDA product code for BRAINLAB MASK SYSTEM is IYE.

Related Clinical Trials

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Other records listing Brainlab Med. Computersysteme GmbH 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.

K970586BRAINLAB MICRO MULTI-LEAF COLLIMATORK954861BRAINLAB CT/X-RAY LOCALIZERK952390BRAINLAB STEROTATIC HEADRINGK934657BRAINLAB LINAC HARDWARE

Related Devices (Code: IYE)

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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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