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FDA 510(k)

BRAINSUITE NET

K-Number: K070556 · 2007-09-25

ApplicantBrainlab AG
Decision Date2007-09-25
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINSUITE NET is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2007-09-25 under 510(k) number K070556. 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 BRAINSUITE NET?

BRAINSUITE NET is a medical device that received FDA 510(k) clearance on 2007-09-25. The listed applicant is Brainlab AG. The 510(k) number is K070556.

When did BRAINSUITE NET receive FDA 510(k) clearance?

BRAINSUITE NET received FDA 510(k) clearance on 2007-09-25, under 510(k) number K070556.

Who is the listed applicant for BRAINSUITE NET?

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 BRAINSUITE NET?

The FDA product code for BRAINSUITE NET is HAW.

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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: 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

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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