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FDA 510(k)

THEMALATOR. MODELS T-4-S, T-8-S, ETC.

K-Number: K950350 · 1995-03-24

ApplicantWhitehall/Div Columbus Mckennon Corp.
Decision Date1995-03-24
Product CodeIRQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THEMALATOR. MODELS T-4-S, T-8-S, ETC. is the device name listed in this FDA 510(k) record. The listed applicant is Whitehall/Div Columbus Mckennon Corp.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K950350. The device is classified under product code IRQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEMALATOR. MODELS T-4-S, T-8-S, ETC.?

THEMALATOR. MODELS T-4-S, T-8-S, ETC. is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Whitehall/Div Columbus Mckennon Corp.. The 510(k) number is K950350.

When did THEMALATOR. MODELS T-4-S, T-8-S, ETC. receive FDA 510(k) clearance?

THEMALATOR. MODELS T-4-S, T-8-S, ETC. received FDA 510(k) clearance on 1995-03-24, under 510(k) number K950350.

Who is the listed applicant for THEMALATOR. MODELS T-4-S, T-8-S, ETC.?

The FDA 510(k) record lists Whitehall/Div Columbus Mckennon Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THEMALATOR. MODELS T-4-S, T-8-S, ETC.?

The FDA product code for THEMALATOR. MODELS T-4-S, T-8-S, ETC. is IRQ.

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Related Devices (Code: IRQ)

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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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