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FDA 510(k)

ACTI-ICP MONITORING SYSTEM

K-Number: K003905 · 2001-06-15

ApplicantInnerspace, Inc.
Decision Date2001-06-15
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTI-ICP MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace, Inc.. It received FDA 510(k) clearance on 2001-06-15 under 510(k) number K003905. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTI-ICP MONITORING SYSTEM?

ACTI-ICP MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-15. The listed applicant is Innerspace, Inc.. The 510(k) number is K003905.

When did ACTI-ICP MONITORING SYSTEM receive FDA 510(k) clearance?

ACTI-ICP MONITORING SYSTEM received FDA 510(k) clearance on 2001-06-15, under 510(k) number K003905.

Who is the listed applicant for ACTI-ICP MONITORING SYSTEM?

The FDA 510(k) record lists Innerspace, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTI-ICP MONITORING SYSTEM?

The FDA product code for ACTI-ICP MONITORING SYSTEM is GWM.

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Other records listing Innerspace, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113088HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)K083378SYNERGYK072379MPS OXIPORT AND MPS OXIPORT PLUSK041838MPS (OR MPS-T)K013705ACT III VENTRICULAR CATHETERK013005ACT 11 MP VENTRICULAR CATHETER

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Related Devices (Code: GWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-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 AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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