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FDA 510(k)

HICP200 Patient/Monitor Interconnect Cable

K-Number: K161010 · 2016-10-20

ApplicantInnerspace Neuro Solutions, Inc.
Decision Date2016-10-20
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HICP200 Patient/Monitor Interconnect Cable is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace Neuro Solutions, Inc.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K161010. 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 HICP200 Patient/Monitor Interconnect Cable?

HICP200 Patient/Monitor Interconnect Cable is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Innerspace Neuro Solutions, Inc.. The 510(k) number is K161010.

When did HICP200 Patient/Monitor Interconnect Cable receive FDA 510(k) clearance?

HICP200 Patient/Monitor Interconnect Cable received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161010.

Who is the listed applicant for HICP200 Patient/Monitor Interconnect Cable?

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

What is the FDA product code for HICP200 Patient/Monitor Interconnect Cable?

The FDA product code for HICP200 Patient/Monitor Interconnect Cable is GWM.

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

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