STARBAND, STARLIGHT— 510(k) K141842

Substantially Equivalent

Orthomerica Products, Inc.

FDA 510(k) clearance K141842 for STARBAND, STARLIGHT, Substantially Equivalent on 2014-10-06. Applicant: Orthomerica Products, Inc.. Device class: 2.

Clearance details

Applicant: Orthomerica Products, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2014-07-08
Decision date: 2014-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MVA

K241957 — Talee, Talee PostOp2024-08-30
K230444 — Talee, Talee PostOp2023-06-22
K223238 — STARband 3D2023-04-20
K220681 — Talee, Talee PostOP2022-09-22
K203134 — Hanger Cranial Band 3D2022-07-01

More clearances from Orthomerica Products, Inc.

K240466 — STARband 3D2024-03-15
K211376 — STARband2021-08-17
K203098 — STARband, STARlight, St. Louis Band2021-04-27
K180109 — STARband, STARlight, St. Louis Band2018-03-01
K161138 — St. Louis Band2016-07-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.