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FDA 510(k)

WAYPOINT STEREOTACTIC SYSTEM

K-Number: K092192 · 2010-02-12

ApplicantFHC, Inc.
Decision Date2010-02-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WAYPOINT STEREOTACTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is FHC, Inc.. It received FDA 510(k) clearance on 2010-02-12 under 510(k) number K092192. 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 WAYPOINT STEREOTACTIC SYSTEM?

WAYPOINT STEREOTACTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is FHC, Inc.. The 510(k) number is K092192.

When did WAYPOINT STEREOTACTIC SYSTEM receive FDA 510(k) clearance?

WAYPOINT STEREOTACTIC SYSTEM received FDA 510(k) clearance on 2010-02-12, under 510(k) number K092192.

Who is the listed applicant for WAYPOINT STEREOTACTIC SYSTEM?

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

What is the FDA product code for WAYPOINT STEREOTACTIC SYSTEM?

The FDA product code for WAYPOINT STEREOTACTIC SYSTEM is HAW.

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Other records listing FHC, Inc. as applicant

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Related Devices (Code: HAW)

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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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