Hot Sack

FDA 510(k) K921395 · C.F. Electronics, Inc.

Substantially Equivalent

510(k) numberK921395

Submission

Device name
Hot Sack
Applicant
C.F. Electronics, Inc.
Commack, NY, US
Received
March 24, 1992
Decision date
September 2, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LGZ – Warmer, Thermal, Infusion Fluid
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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More from Mac Medical, Inc.

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K922786Therm O Drug Model HT-747LGZ · Traditional 01/27/1993SE

Questions and answers

When was Hot Sack cleared by the FDA?

Hot Sack (K921395) received a 510(k) decision of Substantially Equivalent on September 2, 1992, 162 days after the submission was received.

What is the product code of K921395?

The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.