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 a medical device manufactured by Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2018-03-01 under approval 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. It is manufactured by Orthomerica Products, Inc.. The 510(k) number is K180109.
When was STARband, STARlight, St. Louis Band approved by the FDA?
STARband, STARlight, St. Louis Band received FDA 510(k) clearance on 2018-03-01, under approval number K180109.
What company makes STARband, STARlight, St. Louis Band?
STARband, STARlight, St. Louis Band is manufactured by Orthomerica Products, Inc..
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 Devices by Orthomerica Products, Inc.
Related Devices (Code: OAN)
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.