Quickels QS 100 System
FDA 510(k) K954773 · Ferguson Medical
510(k) numberK954773
Submission
- Device name
- Quickels QS 100 System
- Applicant
- Ferguson Medical
Chico, CA, US - Received
- October 13, 1995
- Decision date
- July 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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Questions and answers
When was Quickels QS 100 System cleared by the FDA?
Quickels QS 100 System (K954773) received a 510(k) decision of Substantially Equivalent on July 11, 1996, 272 days after the submission was received.
What is the product code of K954773?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.