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FDA 510(k)

THERMOLATOR HEATING UNIT

K-Number: K801625 · 1980-07-28

ApplicantTru-Eze Mfg. Co., Inc.
Decision Date1980-07-28
Product CodeIRQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMOLATOR HEATING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Tru-Eze Mfg. Co., Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801625. 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 THERMOLATOR HEATING UNIT?

THERMOLATOR HEATING UNIT is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Tru-Eze Mfg. Co., Inc.. The 510(k) number is K801625.

When did THERMOLATOR HEATING UNIT receive FDA 510(k) clearance?

THERMOLATOR HEATING UNIT received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801625.

Who is the listed applicant for THERMOLATOR HEATING UNIT?

The FDA 510(k) record lists Tru-Eze Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOLATOR HEATING UNIT?

The FDA product code for THERMOLATOR HEATING UNIT is IRQ.

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 Tru-Eze Mfg. Co., 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.

K800917TRU-COLD THERAPY PAKK791653REUSABLE MOIST HEAT PACK

Related Devices (Code: IRQ)

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.

K050524EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000Marda Medical, Inc.K950350THEMALATOR. MODELS T-4-S, T-8-S, ETC.Whitehall/Div Columbus Mckennon Corp.K924023FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917FernoK880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)Fred Sammons, Inc.K861340R1750 AND R1424 POWERED HEATING UNITSTri W-G, Inc.K832177PULSAIR MODEL SP-1Thermowave Medical Device Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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