FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLDELFT DIGIDELCA
K Number: K980296
·
Decision Apr 17, 1998
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
9
Review Days
80
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Basic Information
- Device Name
- OLDELFT DIGIDELCA
- K Number
- K980296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oldelft Corp. of America
- Date Received
- January 27, 1998
- Decision Date
- April 17, 1998
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Oldelft Corp. of America
| K Number | Device Name | ||
|---|---|---|---|
| K973219 | AMBER DU | Oct 8, 1997 | Substantially Equivalent |
| K946128 | SIMULIX-HP | May 12, 1995 | Substantially Equivalent |
| K950037 | N 800 HF | Feb 15, 1995 | Substantially Equivalent |
| K932848 | SIMULIX-MC CT EXTENSION | Mar 22, 1994 | Substantially Equivalent |
| K923584 | THERAPAX DXT 300 SERIES 3 | Jan 15, 1993 | Substantially Equivalent |
| K914784 | PAPILLION PROCTOSCOPE | Jun 5, 1992 | Substantially Equivalent |
| K912466 | OLDELFT SIMULIX-MC | Jun 28, 1991 | Substantially Equivalent |
| K892659 | ELECTRODELCA | Nov 21, 1989 | Substantially Equivalent |