EUM 100PRO— 510(k) K131889

Substantially Equivalent

Promedic, Inc.

FDA 510(k) clearance K131889 for EUM 100PRO, Substantially Equivalent on 2014-04-23. Applicant: Promedic, Inc.. Device class: 2.

Clearance details

Applicant: Promedic, Inc.
Product code: Code OSP
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2013-06-25
Decision date: 2014-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSP

K190798 — LaborView LV1000 Wireless Electrode System2020-09-18
K153262 — PUREtrace2017-02-07
K142583 — LaborView LV10002015-01-16
K140862 — MONICA NOVII WIRELESS PATCH SYSTEM2014-08-27
K130002 — SURECALL LABOR MONITOR2013-06-28

More clearances from Promedic, Inc.

K112318 — CLEARPATH 242012-06-29
K072756 — NON-IV ADAPTER FOR INFANT NG TUBE2007-12-19
K060497 — BABYAIR2006-07-11
K060842 — REVJET TURBO2006-06-21
K052903 — PEDIATRIC FEEDING TUBE2005-11-09

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