FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAND, INFUSION
K Number: K946201
·
Decision Apr 18, 1995
Classifications
1
FEI Numbers
278
Registration Numbers
278
Same Product Code
35
Applicant Total
40
Review Days
118
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Basic Information
- Device Name
- STAND, INFUSION
- K Number
- K946201
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6990
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Specialties, Inc.
- Date Received
- December 21, 1994
- Decision Date
- April 18, 1995
- Product Code
- FOX
- 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 |
|---|---|---|---|
| FOX | Stand, Infusion | FDA class 1 | General Hospital |
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Other Clearances by Medical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931947 | CHECKPOINT | Jun 18, 1993 | Substantially Equivalent |
| K926095 | REFRACTROL-SP | Jan 26, 1993 | Substantially Equivalent |
| K924926 | MSI-HCT | Jan 7, 1993 | Substantially Equivalent |
| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Feb 9, 1990 | Substantially Equivalent |
| K883703 | MSI-CAL 7 | Nov 22, 1988 | Substantially Equivalent |
| K883851 | MSI-CAL 8 | Nov 22, 1988 | Substantially Equivalent |
| K883850 | MSI-CAL 16 | Nov 22, 1988 | Substantially Equivalent |
| K880608 | MSI-PC | Mar 21, 1988 | Substantially Equivalent |
| K880270 | MSI-DIFF PLUS | Mar 1, 1988 | Substantially Equivalent |
| K872140 | (MSI) PATH-SAVER | Jun 15, 1987 | Substantially Equivalent |