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 |