The following data is part of a premarket notification filed by Intrgra Lifesciences Corporation with the FDA for Integra Camino Icp Monitor.
| Device ID | K121573 |
| 510k Number | K121573 |
| Device Name: | INTEGRA CAMINO ICP MONITOR |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTRGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Erin Doyle |
| Correspondent | Erin Doyle INTRGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE 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 | 2012-05-29 |
| Decision Date | 2012-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780039310 | K121573 | 000 |
| 10381780121893 | K121573 | 000 |
| M273PMIOMPM11 | K121573 | 000 |
| 00382830048866 | K121573 | 000 |
| M273CAM021 | K121573 | 000 |
| M273CAMCABL1 | K121573 | 000 |
| 10381780039556 | K121573 | 000 |
| 10381780121886 | K121573 | 000 |
| 10381780121879 | K121573 | 000 |
| 10381780039570 | K121573 | 000 |
| 00382830062190 | K121573 | 000 |