FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
N 800 HF
K Number: K950037
·
Decision Feb 15, 1995
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
9
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- N 800 HF
- K Number
- K950037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oldelft Corp. of America
- Date Received
- January 4, 1995
- Decision Date
- February 15, 1995
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZO), ordered by most recent decision date.
MPH50, MPH65, AND MPH80
FDA 510(k)
FDA Class 1
·Radiology
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
N 800 HF
FDA 510(k)
FDA Class 1
·Radiology
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
FDA 510(k)
FDA Class 1
·Radiology
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
POLYDOROS SX 65 AND 80
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Oldelft Corp. of America
| K Number | Device Name | ||
|---|---|---|---|
| K980296 | OLDELFT DIGIDELCA | Apr 17, 1998 | Substantially Equivalent |
| K973219 | AMBER DU | Oct 8, 1997 | Substantially Equivalent |
| K946128 | SIMULIX-HP | May 12, 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 |