GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR— 510(k) K062883

Name: FDA 510(k) clearance K062883
Creator: U.S. Food and Drug Administration
Published: 2007-06-13

Substantially Equivalent

Gereonics, Inc.

FDA 510(k) clearance K062883 for GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR, Substantially Equivalent on 2007-06-13. Applicant: Gereonics, Inc.. Device class: 2.

Clearance details

Applicant: Gereonics, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2006-09-26
Decision date: 2007-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solana Beach, CA, US

Download summary PDF View on FDA.gov ↗

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