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 the device name listed in this FDA 510(k) record. The listed applicant is Odstock Medical, Ltd.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) 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. The listed applicant is Odstock Medical, Ltd.. The 510(k) number is K171396.

When did ODFS Pace XL receive FDA 510(k) clearance?

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

Who is the listed applicant for ODFS Pace XL?

The FDA 510(k) record lists Odstock Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ODFS Pace XL?

The FDA product code for ODFS Pace XL is GZI.

Related Devices (Code: GZI)

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.

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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.