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FDA 510(k)

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

K-Number: K010548 · 2001-03-12

ApplicantRadionics, A Division of Tyco Healthcare Group LP
Decision Date2001-03-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2001-03-12 under 510(k) number K010548. 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 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)?

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) is a medical device that received FDA 510(k) clearance on 2001-03-12. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. The 510(k) number is K010548.

When did MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) receive FDA 510(k) clearance?

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) received FDA 510(k) clearance on 2001-03-12, under 510(k) number K010548.

Who is the listed applicant for MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)?

The FDA 510(k) record lists Radionics, A Division of Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)?

The FDA product code for MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) is HAW.

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Other records listing Radionics, A Division of Tyco Healthcare Group LP 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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