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FDA 510(k)

MR Conditional CGA 870

K-Number: K162811 · 2017-03-02

Decision Date2017-03-02
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MR Conditional CGA 870 is a medical device manufactured by Essex Industries, Inc.. It received FDA 510(k) clearance on 2017-03-02 under approval number K162811. The device is classified under product code CAN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR Conditional CGA 870?

MR Conditional CGA 870 is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Essex Industries, Inc.. The 510(k) number is K162811.

When was MR Conditional CGA 870 approved by the FDA?

MR Conditional CGA 870 received FDA 510(k) clearance on 2017-03-02, under approval number K162811.

What company makes MR Conditional CGA 870?

MR Conditional CGA 870 is manufactured by Essex Industries, Inc..

What is the FDA product code for MR Conditional CGA 870?

The FDA product code for MR Conditional CGA 870 is CAN.

Other Devices by Essex Industries, Inc.

Official Source

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