The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Mobius Multi-modality Monitoring System.
| Device ID | K061640 |
| 510k Number | K061640 |
| Device Name: | INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-12 |
| Decision Date | 2006-07-27 |
| Summary: | summary |