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FDA 510(k)

REGUTHERM 952 THERMOGRAPHIC SYSTEM

K-Number: K003130 · 2001-02-16

ApplicantSie-Med, Inc.
Decision Date2001-02-16
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

REGUTHERM 952 THERMOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sie-Med, Inc.. It received FDA 510(k) clearance on 2001-02-16 under 510(k) number K003130. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGUTHERM 952 THERMOGRAPHIC SYSTEM?

REGUTHERM 952 THERMOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-16. The listed applicant is Sie-Med, Inc.. The 510(k) number is K003130.

When did REGUTHERM 952 THERMOGRAPHIC SYSTEM receive FDA 510(k) clearance?

REGUTHERM 952 THERMOGRAPHIC SYSTEM received FDA 510(k) clearance on 2001-02-16, under 510(k) number K003130.

Who is the listed applicant for REGUTHERM 952 THERMOGRAPHIC SYSTEM?

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

What is the FDA product code for REGUTHERM 952 THERMOGRAPHIC SYSTEM?

The FDA product code for REGUTHERM 952 THERMOGRAPHIC SYSTEM is LHQ.

Related Clinical Trials

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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Other records listing Sie-Med, Inc. as applicant

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.

K964083ULTRATHERM (908)

Related Devices (Code: LHQ)

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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