The following data is part of a premarket notification filed by Ladd Research Industries, Inc. with the FDA for Ladd/steritek Icp Monitor, Cat. No. P3000.
| Device ID | K862820 |
| 510k Number | K862820 |
| Device Name: | LADD/STERITEK ICP MONITOR, CAT. NO. P3000 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | LADD RESEARCH INDUSTRIES, INC. P.O. BOX 1005 Burlington, VT 05402 |
| Contact | John Arnott |
| Correspondent | John Arnott LADD RESEARCH INDUSTRIES, INC. P.O. BOX 1005 Burlington, VT 05402 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-25 |
| Decision Date | 1987-02-26 |