The following data is part of a premarket notification filed by Medical Systems Corp. with the FDA for La Mont Video Patient Monitoring System.
| Device ID | K921485 |
| 510k Number | K921485 |
| Device Name: | LA MONT VIDEO PATIENT MONITORING SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MEDICAL SYSTEMS CORP. SUITE 20/303 PACIFIC HIGHWAY P.O. BOX 4O4, LINDFIELD Nww 2070 Australia, AT |
| Contact | Tony Montgomery |
| Correspondent | Tony Montgomery MEDICAL SYSTEMS CORP. SUITE 20/303 PACIFIC HIGHWAY P.O. BOX 4O4, LINDFIELD Nww 2070 Australia, AT |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-30 |
| Decision Date | 1992-10-22 |