The following data is part of a premarket notification filed by Pharmatrol, Inc. with the FDA for Pharmacokinetics Software System (pps).
| Device ID | K864121 |
| 510k Number | K864121 |
| Device Name: | PHARMACOKINETICS SOFTWARE SYSTEM (PPS) |
| Classification | Medical Computers And Software |
| Applicant | PHARMATROL, INC. 1801 EAST 12TH ST. SUITE NO. 220 Cleveland, OH 44114 |
| Contact | Mark J Hassett |
| Correspondent | Mark J Hassett PHARMATROL, INC. 1801 EAST 12TH ST. SUITE NO. 220 Cleveland, OH 44114 |
| Product Code | LNX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1986-12-10 |