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FDA 510(k)

MR Conditional CGA 870

K-Number: K162811 · 2017-03-02

ApplicantEssex Industries, Inc.
Decision Date2017-03-02
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MR Conditional CGA 870 is the device name listed in this FDA 510(k) record. The listed applicant is Essex Industries, Inc.. It received FDA 510(k) clearance on 2017-03-02 under 510(k) 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. The listed applicant is Essex Industries, Inc.. The 510(k) number is K162811.

When did MR Conditional CGA 870 receive FDA 510(k) clearance?

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

Who is the listed applicant for MR Conditional CGA 870?

The FDA 510(k) record lists Essex Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Essex Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161472Walk-O2-Bout

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.

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