FDA 510(k)

ODFS PACE

K-Number: K102115 · 2011-03-30

Decision Date2011-03-30

Product CodeGZI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ODFS PACE 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 2011-03-30 under 510(k) number K102115. 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?

ODFS PACE is a medical device that received FDA 510(k) clearance on 2011-03-30. The listed applicant is Odstock Medical, Ltd.. The 510(k) number is K102115.

When did ODFS PACE receive FDA 510(k) clearance?

ODFS PACE received FDA 510(k) clearance on 2011-03-30, under 510(k) number K102115.

Who is the listed applicant for ODFS PACE?

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?

The FDA product code for ODFS PACE is GZI.

Other records listing Odstock Medical, Ltd. 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.

K171396ODFS Pace XL

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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.