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FDA 510(k)

BRAINLAB STEROTATIC HEADRING

K-Number: K952390 · 1996-02-02

ApplicantBrainlab Med. Computersysteme GmbH
Decision Date1996-02-02
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINLAB STEROTATIC HEADRING 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 1996-02-02 under 510(k) number K952390. 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 BRAINLAB STEROTATIC HEADRING?

BRAINLAB STEROTATIC HEADRING is a medical device that received FDA 510(k) clearance on 1996-02-02. The listed applicant is Brainlab Med. Computersysteme GmbH. The 510(k) number is K952390.

When did BRAINLAB STEROTATIC HEADRING receive FDA 510(k) clearance?

BRAINLAB STEROTATIC HEADRING received FDA 510(k) clearance on 1996-02-02, under 510(k) number K952390.

Who is the listed applicant for BRAINLAB STEROTATIC HEADRING?

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 STEROTATIC HEADRING?

The FDA product code for BRAINLAB STEROTATIC HEADRING is HAW.

Related Clinical Trials

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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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 LOCALIZERK945903BRAINLAB MASK SYSTEMK934657BRAINLAB LINAC HARDWARE

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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