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FDA 510(k)

CRT2000 THERMOGRAPHIC SYSTEM

K-Number: K971956 · 1997-08-22

ApplicantWerner Eidam Medizin-Technologie GmbH
Decision Date1997-08-22
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CRT2000 THERMOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Werner Eidam Medizin-Technologie GmbH. It received FDA 510(k) clearance on 1997-08-22 under 510(k) number K971956. 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 CRT2000 THERMOGRAPHIC SYSTEM?

CRT2000 THERMOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-22. The listed applicant is Werner Eidam Medizin-Technologie GmbH. The 510(k) number is K971956.

When did CRT2000 THERMOGRAPHIC SYSTEM receive FDA 510(k) clearance?

CRT2000 THERMOGRAPHIC SYSTEM received FDA 510(k) clearance on 1997-08-22, under 510(k) number K971956.

Who is the listed applicant for CRT2000 THERMOGRAPHIC SYSTEM?

The FDA 510(k) record lists Werner Eidam Medizin-Technologie GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRT2000 THERMOGRAPHIC SYSTEM?

The FDA product code for CRT2000 THERMOGRAPHIC SYSTEM is LHQ.

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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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