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FDA 510(k)

LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE

K-Number: K946033 · 1995-09-01

ApplicantLeibinger GmbH
Decision Date1995-09-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Leibinger GmbH. It received FDA 510(k) clearance on 1995-09-01 under 510(k) number K946033. 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 LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE?

LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Leibinger GmbH. The 510(k) number is K946033.

When did LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE receive FDA 510(k) clearance?

LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE received FDA 510(k) clearance on 1995-09-01, under 510(k) number K946033.

Who is the listed applicant for LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE?

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

What is the FDA product code for LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE?

The FDA product code for LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE is HAW.

Related Clinical Trials

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Other records listing Leibinger 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.

K954030BONE-LOCKK924685STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM

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.

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Official Source

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