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FDA 510(k)

Encompass SRS Headframe ; Encompass MR SRS Headframe

K-Number: K182189 · 2018-10-04

ApplicantQfix
Decision Date2018-10-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Encompass SRS Headframe ; Encompass MR SRS Headframe is a medical device manufactured by Qfix. It received FDA 510(k) clearance on 2018-10-04 under approval number K182189. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Encompass SRS Headframe ; Encompass MR SRS Headframe?

Encompass SRS Headframe ; Encompass MR SRS Headframe is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Qfix. The 510(k) number is K182189.

When was Encompass SRS Headframe ; Encompass MR SRS Headframe approved by the FDA?

Encompass SRS Headframe ; Encompass MR SRS Headframe received FDA 510(k) clearance on 2018-10-04, under approval number K182189.

What company makes Encompass SRS Headframe ; Encompass MR SRS Headframe?

Encompass SRS Headframe ; Encompass MR SRS Headframe is manufactured by Qfix.

What is the FDA product code for Encompass SRS Headframe ; Encompass MR SRS Headframe?

The FDA product code for Encompass SRS Headframe ; Encompass MR SRS Headframe is IYE.

Other Devices by Qfix

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Official Source

View on FDA Database →

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

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