Raumedic-Pto-Monitoring-System

FDA 510(k) K130529 · Raumedic AG

Substantially Equivalent

510(k) numberK130529

Submission

Device name
Raumedic-Pto-Monitoring-System
Applicant
Raumedic AG
Helmbrechts, DE
Received
March 1, 2013
Decision date
October 25, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
GWM – Device, Monitoring, Intracranial Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1620
Specialty
Neurology

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More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.

510(k)DeviceDecision
K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…GWM · Traditional 08/29/2025SE
K171666MPR2 logO DATALOGGERGWM · Traditional 07/06/2017SE
K120252Raumedic-Icp-Temp-Monitoring-SystemGWM · Traditional 04/11/2012SE
K112017Raumedic Icp Monitoring SystemGWM · Traditional 10/11/2011SE
K103206Raumedic- Icp-Monitoring SystemGWM · Traditional 03/04/2011SE

Questions and answers

When was Raumedic-Pto-Monitoring-System cleared by the FDA?

Raumedic-Pto-Monitoring-System (K130529) received a 510(k) decision of Substantially Equivalent on October 25, 2013, 238 days after the submission was received.

What is the product code of K130529?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.