The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Intracranial Pressure Monitoring Kit 070.
| Device ID | K853864 |
| 510k Number | K853864 |
| Device Name: | INTRACRANIAL PRESSURE MONITORING KIT 070 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Dan Mckay |
| Correspondent | Dan Mckay CAMINO LABORATORIES, 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 | 1985-09-17 |
| Decision Date | 1986-02-20 |