FDA 510(k)

STARband

K-Number: K211376 · 2021-08-17

Decision Date2021-08-17

Product CodeOAN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STARband 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 2021-08-17 under 510(k) 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. The listed applicant is Orthomerica Products, Inc.. The 510(k) number is K211376.

When did STARband receive FDA 510(k) clearance?

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

Who is the listed applicant for STARband?

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 STARband?

The FDA product code for STARband 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 K203098STARband, STARlight, St. Louis Band K180109STARband, STARlight, St. Louis Band K161138St. Louis Band

Related Devices (Code: OAN)

K244056DOC Band 3DCranial Technologies, Inc.K240466STARband 3DOrthomerica Products, Inc.K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K161138St. 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.