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FDA 510(k)

STARband, STARlight, St. Louis Band

K-Number: K180109 · 2018-03-01

ApplicantOrthomerica Products, Inc.
Decision Date2018-03-01
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STARband, STARlight, 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 2018-03-01 under 510(k) number K180109. 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, STARlight, St. Louis Band?

STARband, STARlight, St. Louis Band is a medical device that received FDA 510(k) clearance on 2018-03-01. The listed applicant is Orthomerica Products, Inc.. The 510(k) number is K180109.

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

STARband, STARlight, St. Louis Band received FDA 510(k) clearance on 2018-03-01, under 510(k) number K180109.

Who is the listed applicant for STARband, STARlight, 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 STARband, STARlight, St. Louis Band?

The FDA product code for STARband, STARlight, 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 3DK223238STARband 3DK211376STARbandK203098STARband, STARlight, St. Louis BandK161138St. Louis Band

Related Devices (Code: OAN)

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.

K244056DOC Band 3DCranial Technologies, Inc.K240466STARband 3DOrthomerica Products, Inc.K211376STARbandOrthomerica Products, Inc.K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K161138St. Louis BandOrthomerica Products, 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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