The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Licox Pmo Brain Monitoring System.
| Device ID | K040235 |
| 510k Number | K040235 |
| Device Name: | LICOX PMO BRAIN MONITORING SYSTEM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Nancy Mathewson |
| Correspondent | Nancy Mathewson 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 | 2004-02-02 |
| Decision Date | 2004-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780250043 | K040235 | 000 |
| M272VK521 | K040235 | 000 |
| 10381780250074 | K040235 | 000 |
| M272IP11 | K040235 | 000 |
| M272IP21 | K040235 | 000 |
| M273CC1P11 | K040235 | 000 |
| M273IP1P1 | K040235 | 000 |
| M273IP2P1 | K040235 | 000 |
| M272CC1P11 | K040235 | 000 |
| M272IP1P1 | K040235 | 000 |
| M272IP2P1 | K040235 | 000 |
| M273PMOBOX1 | K040235 | 000 |
| M273VK521 | K040235 | 000 |