FDA 510(k)

St. Louis Band

K-Number: K161138 · 2016-07-20

Decision Date2016-07-20

Product CodeOAN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

St. Louis Band is the device name listed in this FDA 510(k) record. The listed applicant is Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K161138. The device is classified under product code OAN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the St. Louis Band?

St. Louis Band is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Orthomerica Products, Inc.. The 510(k) number is K161138.

When did St. Louis Band receive FDA 510(k) clearance?

St. Louis Band received FDA 510(k) clearance on 2016-07-20, under 510(k) number K161138.

Who is the listed applicant for St. Louis Band?

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

What is the FDA product code for St. Louis Band?

The FDA product code for St. Louis Band is OAN.

Other records listing Orthomerica Products, 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.

K240466STARband 3D K223238STARband 3D K211376STARband K203098STARband, STARlight, St. Louis Band K180109STARband, STARlight, St. Louis Band

Related Devices (Code: OAN)

K244056DOC Band 3DCranial Technologies, Inc.K240466STARband 3DOrthomerica Products, Inc.K211376STARbandOrthomerica Products, Inc.K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.

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.