The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Quickels Qs 100 System.
| Device ID | K954773 |
| 510k Number | K954773 |
| Device Name: | QUICKELS QS 100 SYSTEM |
| Classification | Electrode, Electrocardiograph |
| Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1996-07-11 |
| Summary: | summary |