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FDA 510(k)

THERMOSUIT SYSTEM

K-Number: K061023 · 2006-09-20

ApplicantLife Recovery Systems Hd, LLC
Decision Date2006-09-20
Product CodeNZE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMOSUIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Recovery Systems Hd, LLC. It received FDA 510(k) clearance on 2006-09-20 under 510(k) number K061023. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOSUIT SYSTEM?

THERMOSUIT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-20. The listed applicant is Life Recovery Systems Hd, LLC. The 510(k) number is K061023.

When did THERMOSUIT SYSTEM receive FDA 510(k) clearance?

THERMOSUIT SYSTEM received FDA 510(k) clearance on 2006-09-20, under 510(k) number K061023.

Who is the listed applicant for THERMOSUIT SYSTEM?

The FDA 510(k) record lists Life Recovery Systems Hd, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOSUIT SYSTEM?

The FDA product code for THERMOSUIT SYSTEM is NZE.

Related Clinical Trials

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Related Devices (Code: NZE)

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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