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FDA 510(k)

HTS EXTREMITY COIL, HTS SURFACE COIL

K-Number: K112293 · 2011-09-30

ApplicantTime Medical Systems, Inc.
Decision Date2011-09-30
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HTS EXTREMITY COIL, HTS SURFACE COIL is the device name listed in this FDA 510(k) record. The listed applicant is Time Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K112293. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HTS EXTREMITY COIL, HTS SURFACE COIL?

HTS EXTREMITY COIL, HTS SURFACE COIL is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Time Medical Systems, Inc.. The 510(k) number is K112293.

When did HTS EXTREMITY COIL, HTS SURFACE COIL receive FDA 510(k) clearance?

HTS EXTREMITY COIL, HTS SURFACE COIL received FDA 510(k) clearance on 2011-09-30, under 510(k) number K112293.

Who is the listed applicant for HTS EXTREMITY COIL, HTS SURFACE COIL?

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

What is the FDA product code for HTS EXTREMITY COIL, HTS SURFACE COIL?

The FDA product code for HTS EXTREMITY COIL, HTS SURFACE COIL is MOS.

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Related Devices (Code: MOS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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