The following data is part of a premarket notification filed by Camino Neurocare, Inc. with the FDA for Combined Intracranial Pressure-temperature Sensing System (icp/).
| Device ID | K962928 |
| 510k Number | K962928 |
| Device Name: | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CAMINO NEUROCARE, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Donna L Free |
| Correspondent | Donna L Free CAMINO NEUROCARE, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-29 |
| Decision Date | 1996-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830047531 | K962928 | 000 |