The following data is part of a premarket notification filed by Alternative Design Systems, Inc. with the FDA for Monitoring Kit Amk-1.
| Device ID | K830778 |
| 510k Number | K830778 |
| Device Name: | MONITORING KIT AMK-1 |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | ALTERNATIVE DESIGN SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-11 |
| Decision Date | 1983-10-14 |