PUREtrace— 510(k) K153262

Substantially Equivalent

Nemo Healthcare BV

FDA 510(k) clearance K153262 for PUREtrace, Substantially Equivalent on 2017-02-07. Applicant: Nemo Healthcare BV. Device class: 2.

Clearance details

Applicant: Nemo Healthcare BV
Product code: Code OSP
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2015-11-10
Decision date: 2017-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Veldhoven, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSP

K190798 — LaborView LV1000 Wireless Electrode System2020-09-18
K142583 — LaborView LV10002015-01-16
K140862 — MONICA NOVII WIRELESS PATCH SYSTEM2014-08-27
K131889 — EUM 100PRO2014-04-23
K130002 — SURECALL LABOR MONITOR2013-06-28

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