The following data is part of a premarket notification filed by Innerspace, Inc. with the FDA for Acti-icp Monitoring System.
| Device ID | K003905 |
| 510k Number | K003905 |
| Device Name: | ACTI-ICP MONITORING SYSTEM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INNERSPACE, INC. 2933 SOUTH PULLMAN ST., SUITE A Santa Ana, CA 92705 |
| Contact | Donald E Bobo |
| Correspondent | Donald E Bobo INNERSPACE, INC. 2933 SOUTH PULLMAN ST., SUITE A Santa Ana, CA 92705 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-19 |
| Decision Date | 2001-06-15 |