The following data is part of a premarket notification filed by Integra Neuro Sciences with the FDA for Camino Single Parameter Monitor, Model Spm-1.
| Device ID | K031086 |
| 510k Number | K031086 |
| Device Name: | CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA NEURO SCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Nancy A Mathewson |
| Correspondent | Nancy A Mathewson INTEGRA NEURO SCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-07 |
| Decision Date | 2003-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M273PMIOSPM1 | K031086 | 000 |
| M273PAC21 | K031086 | 000 |