The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Integra Licox Pto2 Monitor.
| Device ID | K131184 |
| 510k Number | K131184 |
| Device Name: | INTEGRA LICOX PTO2 MONITOR |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA LIFESCIENCES CORP. 22 TERRY AVENUE Burlington, MA 01830 |
| Contact | Elizabeth Mcmeniman |
| Correspondent | Elizabeth Mcmeniman INTEGRA LIFESCIENCES CORP. 22 TERRY AVENUE Burlington, MA 01830 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-25 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M273LCXO21 | K131184 | 000 |