FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKELS QS 200 SYSTEM
K Number: K954772
·
Decision Jul 11, 1996
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
57
Review Days
272
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Basic Information
- Device Name
- QUICKELS QS 200 SYSTEM
- K Number
- K954772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ferguson Medical
- Date Received
- October 13, 1995
- Decision Date
- July 11, 1996
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | May 22, 1997 | Substantially Equivalent |