FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
EPISENSOR PLUS
K Number: K920740
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
5
Review Days
747
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Basic Information
- Device Name
- EPISENSOR PLUS
- K Number
- K920740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2460
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Industrias Palex C/O Dma Med-Chem Corp.
- Date Received
- February 19, 1992
- Decision Date
- March 7, 1994
- Product Code
- CAR
- 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 |
|---|---|---|---|
| CAR | Monitor, Spinal-Fluid Pressure, Electrically Powered | FDA class 2 | General Hospital |
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Other Clearances by Industrias Palex C/O Dma Med-Chem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K920366 | ULCUFLEX HYDROCOLOID POWDER | Mar 26, 1992 | Substantially Equivalent |
| K920367 | ULCUFLEX HYDROCULLOID DRESSING | Mar 26, 1992 | Substantially Equivalent |
| K920368 | ULCUFLEX HYDROCOLLOID PASTE | Mar 26, 1992 | Substantially Equivalent |
| K871628 | PALEX (R) OSTOMY | Jul 8, 1987 | Substantially Equivalent |