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FDA 510(k)

OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS

K-Number: K983669 · 1998-11-18

ApplicantRadionics, Inc.
Decision Date1998-11-18
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K983669. 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 OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS?

OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Radionics, Inc.. The 510(k) number is K983669.

When did OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS receive FDA 510(k) clearance?

OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983669.

Who is the listed applicant for OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS?

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

What is the FDA product code for OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS?

The FDA product code for OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS is HAW.

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Other records listing Radionics, Inc. as applicant

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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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