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510(k) K252241

Device
Pressio 3 Multi-parameter Neuromonitoring System
Applicant
Sophysa
510(k) number
K252241
Product code
GWM
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-10
Date received
2025-07-17
Regulation
882.1620
Classification name
Device, Monitoring, Intracranial Pressure
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Julie Lopez
Address
5 Rue Guy Môquet Orsay FR 91400 91400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AG2025-08-29
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K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.2016-10-20