FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDX REUSABLE SHARPS CONTAINER
K Number: K943771
·
Decision Mar 3, 1995
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
213
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Basic Information
- Device Name
- MEDX REUSABLE SHARPS CONTAINER
- K Number
- K943771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bfi- Medical Waste Systems
- Date Received
- August 2, 1994
- Decision Date
- March 3, 1995
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Bfi- Medical Waste Systems
| K Number | Device Name | ||
|---|---|---|---|
| K981184 | SHARPTRACK REUSABLE SHARPS CONTAINER | Jun 22, 1998 | Substantially Equivalent |
| K943794 | MX4000 | Dec 14, 1994 | Substantially Equivalent |
| K923356 | MEDX ROTATIONAL GANTRY SYSTEM | Sep 21, 1992 | Substantially Equivalent |
| K843582 | MULTI-FORMAT FILM CAMERA | Oct 25, 1984 | Substantially Equivalent |
| K827761 | MED-X MODEL 301 X-RAY FILTER | Aug 10, 1982 | Substantially Equivalent |