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FDA 510(k)

STARband

K-Number: K211376 · 2021-08-17

ApplicantOrthomerica Products, Inc.
Decision Date2021-08-17
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STARband is a medical device manufactured by Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2021-08-17 under approval number K211376. 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 STARband?

STARband is a medical device that received FDA 510(k) clearance on 2021-08-17. It is manufactured by Orthomerica Products, Inc.. The 510(k) number is K211376.

When was STARband approved by the FDA?

STARband received FDA 510(k) clearance on 2021-08-17, under approval number K211376.

What company makes STARband?

STARband is manufactured by Orthomerica Products, Inc..

What is the FDA product code for STARband?

The FDA product code for STARband is OAN.

Other Devices by Orthomerica Products, Inc.

K161138St. Louis Band K180109STARband, STARlight, St. Louis Band K203098STARband, STARlight, St. Louis Band K223238STARband 3D K240466STARband 3D

Related Devices (Code: OAN)

K161138St. Louis BandOrthomerica Products, Inc. K180109STARband, STARlight, St. Louis BandOrthomerica 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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