The following data is part of a premarket notification filed by Innerspace Medical, Inc. with the FDA for Opx-vx Feberoptic Intracranial Pressure Monitoring Catheter With Drainage.
| Device ID | K943987 |
| 510k Number | K943987 |
| Device Name: | OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INNERSPACE MEDICAL, INC. 1923 S.E. MAIN ST. Irvine, CA 92714 |
| Contact | Nancy E Shadforth |
| Correspondent | Nancy E Shadforth INNERSPACE MEDICAL, INC. 1923 S.E. MAIN ST. Irvine, CA 92714 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-12-07 |