The following data is part of a premarket notification filed by Camino Neurocare, Inc. with the FDA for Parenchymal Bolt Pressure Monitoring Kit.
| Device ID | K981846 |
| 510k Number | K981846 |
| Device Name: | PARENCHYMAL BOLT PRESSURE MONITORING KIT |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CAMINO NEUROCARE, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Jody J Fleming |
| Correspondent | Jody J Fleming 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 | 1998-05-26 |
| Decision Date | 1998-08-18 |