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FDA 510(k)

MPS (OR MPS-T)

K-Number: K041838 · 2005-03-01

ApplicantInnerspace, Inc.
Decision Date2005-03-01
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MPS (OR MPS-T) is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace, Inc.. It received FDA 510(k) clearance on 2005-03-01 under 510(k) number K041838. 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 MPS (OR MPS-T)?

MPS (OR MPS-T) is a medical device that received FDA 510(k) clearance on 2005-03-01. The listed applicant is Innerspace, Inc.. The 510(k) number is K041838.

When did MPS (OR MPS-T) receive FDA 510(k) clearance?

MPS (OR MPS-T) received FDA 510(k) clearance on 2005-03-01, under 510(k) number K041838.

Who is the listed applicant for MPS (OR MPS-T)?

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 MPS (OR MPS-T)?

The FDA product code for MPS (OR MPS-T) is GWM.

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 PLUSK013705ACT III VENTRICULAR CATHETERK013005ACT 11 MP VENTRICULAR CATHETERK010422ACT II ICP MONITORING SYSTEM AND 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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