T-350 Therapeutic Cooling Machine

FDA 510(k) K950711 · Thermotek, Inc.

Substantially Equivalent

510(k) numberK950711

Submission

Device name
T-350 Therapeutic Cooling Machine
Applicant
Thermotek, Inc.
Carrollton, TX, US
Received
February 14, 1995
Decision date
July 6, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ILO – Pack, Hot Or Cold, Water Circulating
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5720
Specialty
Physical Medicine

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Questions and answers

When was T-350 Therapeutic Cooling Machine cleared by the FDA?

T-350 Therapeutic Cooling Machine (K950711) received a 510(k) decision of Substantially Equivalent on July 6, 1995, 142 days after the submission was received.

What is the product code of K950711?

The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.