SUDOSCAN— 510(k) K141872

Substantially Equivalent

Impeto Medical, Inc.

FDA 510(k) clearance K141872 for SUDOSCAN, Substantially Equivalent on 2014-11-21. Applicant: Impeto Medical, Inc.. Device class: 2.

Clearance details

Applicant: Impeto Medical, Inc.
Product code: Code GZO
Device class: Class 2
Regulation: 21 CFR 882.1540
Advisory panel: Neurology
Date received: 2014-07-11
Decision date: 2014-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZO

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K102166 — ELECTRO INTERSTITIAL SCAN2010-12-10

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