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FDA 510(k)

THERMO-5000

K-Number: K895358 · 1990-05-07

ApplicantMedtronix Ltd., Inc.
Decision Date1990-05-07
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THERMO-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronix Ltd., Inc.. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K895358. 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 THERMO-5000?

THERMO-5000 is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is Medtronix Ltd., Inc.. The 510(k) number is K895358.

When did THERMO-5000 receive FDA 510(k) clearance?

THERMO-5000 received FDA 510(k) clearance on 1990-05-07, under 510(k) number K895358.

Who is the listed applicant for THERMO-5000?

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

What is the FDA product code for THERMO-5000?

The FDA product code for THERMO-5000 is LHQ.

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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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