FDA 510(k)

ODFS Pace XL

K-Number: K171396 · 2018-01-31

Decision Date2018-01-31

Product CodeGZI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ODFS Pace XL is a medical device manufactured by Odstock Medical, Ltd.. It received FDA 510(k) clearance on 2018-01-31 under approval number K171396. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODFS Pace XL?

ODFS Pace XL is a medical device that received FDA 510(k) clearance on 2018-01-31. It is manufactured by Odstock Medical, Ltd.. The 510(k) number is K171396.

When was ODFS Pace XL approved by the FDA?

ODFS Pace XL received FDA 510(k) clearance on 2018-01-31, under approval number K171396.

What company makes ODFS Pace XL?

ODFS Pace XL is manufactured by Odstock Medical, Ltd..

What is the FDA product code for ODFS Pace XL?

The FDA product code for ODFS Pace XL is GZI.

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Official Source

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