RHS HELMET— 510(k) K012007

Substantially Equivalent

Restorative Health Svs, Inc.

FDA 510(k) clearance K012007 for RHS HELMET, Substantially Equivalent on 2001-09-19. Applicant: Restorative Health Svs, Inc.. Device class: 2.

Clearance details

Applicant: Restorative Health Svs, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-06-27
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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