FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METRICARE DRUG RESERVOIRS
K Number: K895924
·
Decision Jul 26, 1990
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
5
Review Days
288
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Basic Information
- Device Name
- METRICARE DRUG RESERVOIRS
- K Number
- K895924
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Metrix Co.
- Date Received
- October 11, 1989
- Decision Date
- July 26, 1990
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Metrix Co.
| K Number | Device Name | ||
|---|---|---|---|
| K030888 | EVA EMPTY SOLUTION CONTAINER | Apr 2, 2003 | Substantially Equivalent |
| K895922 | METRICARE EMPTY CONTAINER SYSTEMS | Aug 22, 1990 | Substantially Equivalent |
| K895923 | METRICARE ENTERAL FEEDING SYSTEM | Jul 19, 1990 | Substantially Equivalent |
| K761201 | ECHO-CARDIOTRACE, AUTOMATIC | Jan 12, 1977 | Substantially Equivalent |