FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFUSION PUMP ACCESS. #60-01-5
K Number: K830317
·
Decision Mar 31, 1983
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
47
Applicant Total
9
Review Days
59
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Basic Information
- Device Name
- INFUSION PUMP ACCESS. #60-01-5
- K Number
- K830317
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2720
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Windsor Medical, Inc.
- Date Received
- January 31, 1983
- Decision Date
- March 31, 1983
- Product Code
- FRW
- 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 |
|---|---|---|---|
| FRW | Scale, Patient | FDA class 1 | General Hospital |
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Other Clearances by Windsor Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841481 | WINDSOR MEDICAL MODEL 50-00002 | May 21, 1984 | Substantially Equivalent |
| K832606 | WINDSOR MEDICAL VARIOUS MODELS | Nov 29, 1983 | Substantially Equivalent |
| K832641 | WINDSOR MEDICAL MODEL 52 | Oct 4, 1983 | Substantially Equivalent |
| K830657 | AMBULATORY MARK XI DRUG INFUSION DEV- | Sep 16, 1983 | Substantially Equivalent |
| K830656 | AMBULATORY MARK III INFUSION DEVICE | Aug 16, 1983 | Substantially Equivalent |
| K830490 | MODEL 50-01-27 | Mar 31, 1983 | Substantially Equivalent |
| K830544 | WINDSOR MEDICAL, INC. 50-01-028 | Mar 31, 1983 | Substantially Equivalent |
| K822842 | AMBULATORY MARK I | Mar 24, 1983 | Substantially Equivalent |