The following data is part of a premarket notification filed by Individual Monitoring Systems, Inc. with the FDA for Pam-rl.
| Device ID | K010997 |
| 510k Number | K010997 |
| Device Name: | PAM-RL |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | INDIVIDUAL MONITORING SYSTEMS, INC. 1055 TAYLOR AVE., SUITE 300 Baltimore, MD 21286 -8334 |
| Contact | David T Krausman |
| Correspondent | David T Krausman INDIVIDUAL MONITORING SYSTEMS, INC. 1055 TAYLOR AVE., SUITE 300 Baltimore, MD 21286 -8334 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-03 |
| Decision Date | 2001-10-15 |