HICP200 Patient/Monitor Interconnect Cable

Device, Monitoring, Intracranial Pressure

InnerSpace Neuro Solutions, Inc.

The following data is part of a premarket notification filed by Innerspace Neuro Solutions, Inc. with the FDA for Hicp200 Patient/monitor Interconnect Cable.

Pre-market Notification Details

• Device ID: K161010
• 510k Number: K161010
• Device Name: HICP200 Patient/Monitor Interconnect Cable
• Classification: Device, Monitoring, Intracranial Pressure
• Applicant: InnerSpace Neuro Solutions, Inc. 1622 Edinger Ave Suite C Tustin, CA 92780
• Contact: Gary G. Frugard
• Correspondent: Gary G. Frugard; InnerSpace Neuro Solutions, Inc. 1622 Edinger Ave Suite C Tustin, CA 92780
• Product Code: GWM
• CFR Regulation Number: 882.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-11
• Decision Date: 2016-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851680007151	K161010	000
10850013266019	K161010	000