MPR2 logO DATALOGGER
FDA 510(k) K171666 · Raumedic AG
510(k) numberK171666
Submission
- Device name
- MPR2 logO DATALOGGER
- Applicant
- Raumedic AG
Helmbrechts, DE - Received
- June 5, 2017
- Decision date
- July 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code GWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional | Sophysa | 04/10/2026SE |
| K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…GWM · Traditional | Raumedic AG | 08/29/2025SE |
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWM · Traditional | Braincare Desenvolvimento E Inovação Tecnológica… | 07/18/2024SE |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM · Traditional | Integra Lifesciences Production Corporation | 02/04/2024SE |
| K201989 | B4C SystemGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/08/2021SE |
| K210993 | CereLink ICP MonitorGWM · Special | Integra Lifesciences Production Corporation | 04/30/2021SE |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…GWM · Special | Medtronic, Inc. | 05/26/2020SE |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and…GWM · Special | Medtronic, Inc. | 04/09/2020SE |
| K200456 | Becker External Drainage and Monitoring SystemGWM · Special | Medtronic, Inc. | 03/26/2020SE |
| K182073 | BcSs-PICNI-2000 SensorGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/17/2019SE |
More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…GWM · Traditional | 08/29/2025SE |
| K130529 | Raumedic-Pto-Monitoring-SystemGWM · Traditional | 10/25/2013SE |
| K120252 | Raumedic-Icp-Temp-Monitoring-SystemGWM · Traditional | 04/11/2012SE |
| K112017 | Raumedic Icp Monitoring SystemGWM · Traditional | 10/11/2011SE |
| K103206 | Raumedic- Icp-Monitoring SystemGWM · Traditional | 03/04/2011SE |
Questions and answers
When was MPR2 logO DATALOGGER cleared by the FDA?
MPR2 logO DATALOGGER (K171666) received a 510(k) decision of Substantially Equivalent on July 6, 2017, 31 days after the submission was received.
What is the product code of K171666?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.