Mark Vii Thermoregulation Assist System

FDA 510(k) K900355 · Life Enhancement Technologies, LLC

Substantially Equivalent

510(k) numberK900355

Submission

Device name
Mark Vii Thermoregulation Assist System
Applicant
Life Enhancement Technologies, LLC
Bethesda, MD, US
Received
January 25, 1990
Decision date
February 15, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Mark Vii Thermoregulation Assist System cleared by the FDA?

Mark Vii Thermoregulation Assist System (K900355) received a 510(k) decision of Substantially Equivalent on February 15, 1990, 21 days after the submission was received.

What is the product code of K900355?

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