MR Conditional CGA 870

FDA 510(k) K162811 · Essex Industries, Inc.

Substantially Equivalent

510(k) numberK162811

Submission

Device name
MR Conditional CGA 870
Applicant
Essex Industries, Inc.
St. Louis, MO, US
Received
October 6, 2016
Decision date
March 2, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAN – Regulator, Pressure, Gas Cylinder
Device class
Class I (low risk)
Regulation
21 CFR 868.2700
Specialty
Anesthesiology

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Questions and answers

When was MR Conditional CGA 870 cleared by the FDA?

MR Conditional CGA 870 (K162811) received a 510(k) decision of Substantially Equivalent on March 2, 2017, 147 days after the submission was received.

What is the product code of K162811?

The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.