The following data is part of a premarket notification filed by Ladd Research Industries, Inc. with the FDA for Ladd Medical S-2000.
| Device ID | K862012 |
| 510k Number | K862012 |
| Device Name: | LADD MEDICAL S-2000 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | LADD RESEARCH INDUSTRIES, INC. P.O. BOX 1005 Burlington, VT 05402 |
| Contact | Michael Rainey |
| Correspondent | Michael Rainey 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 | 1986-05-28 |
| Decision Date | 1986-06-09 |