SYNERGY

Device, Monitoring, Intracranial Pressure

INNERSPACE, INC.

The following data is part of a premarket notification filed by Innerspace, Inc. with the FDA for Synergy.

Pre-market Notification Details

• Device ID: K083378
• 510k Number: K083378
• Device Name: SYNERGY
• Classification: Device, Monitoring, Intracranial Pressure
• Applicant: INNERSPACE, INC. 1622 EDINGER AVENUE, SUITE C Tustin, CA 92780
• Contact: Don Bobo
• Correspondent: Don Bobo; INNERSPACE, INC. 1622 EDINGER AVENUE, SUITE C Tustin, CA 92780
• Product Code: GWM
• CFR Regulation Number: 882.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-14
• Decision Date: 2009-09-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851680007205	K083378	000
00851680007199	K083378	000
00851680007182	K083378	000
00851680007175	K083378	000
10850013266033	K083378	000
10850013266026	K083378	000
10850013266279	K083378	000