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FDA 510(k)

TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE

K-Number: K092366 · 2010-03-04

ApplicantThermal Therapeutic Systems, Inc.
Decision Date2010-03-04
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Thermal Therapeutic Systems, Inc.. It received FDA 510(k) clearance on 2010-03-04 under 510(k) number K092366. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE?

TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE is a medical device that received FDA 510(k) clearance on 2010-03-04. The listed applicant is Thermal Therapeutic Systems, Inc.. The 510(k) number is K092366.

When did TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE receive FDA 510(k) clearance?

TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE received FDA 510(k) clearance on 2010-03-04, under 510(k) number K092366.

Who is the listed applicant for TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE?

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

What is the FDA product code for TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE?

The FDA product code for TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE is LGZ.

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Related Devices (Code: LGZ)

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

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