The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Quickels Qs 200 System.
Device ID | K954772 |
510k Number | K954772 |
Device Name: | QUICKELS QS 200 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 |