The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Ventricular Pressure Monitoring Kit, Model 110-4hm.
| Device ID | K914735 |
| 510k Number | K914735 |
| Device Name: | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Marie Aker |
| Correspondent | Marie Aker 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 | 1991-10-21 |
| Decision Date | 1992-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780258049 | K914735 | 000 |