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FDA 510(k)

St. Louis Band

K-Number: K161138 · 2016-07-20

ApplicantOrthomerica Products, Inc.
Decision Date2016-07-20
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

St. Louis Band is a medical device manufactured by Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2016-07-20 under approval 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. It is manufactured by Orthomerica Products, Inc.. The 510(k) number is K161138.

When was St. Louis Band approved by the FDA?

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

What company makes St. Louis Band?

St. Louis Band is manufactured by Orthomerica Products, Inc..

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

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

Other Devices by Orthomerica Products, Inc.

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

Related Devices (Code: OAN)

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

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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