FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEP 90
K Number: K904103
·
Decision Nov 20, 1990
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
9
Applicant Total
11
Review Days
75
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Basic Information
- Device Name
- SEP 90
- K Number
- K904103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1870
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Elema-Schonander, Inc.
- Date Received
- September 6, 1990
- Decision Date
- November 20, 1990
- Product Code
- IZP
- 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 |
|---|---|---|---|
| IZP | Programmer, Changer, Film/Cassette, Radiographic | FDA class 2 | Radiology |
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SEP PROGRAMMER FOR PUCK U & UD FILMCHANG
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Other Clearances by Elema-Schonander, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934944 | MPQ-42 | Dec 15, 1993 | Substantially Equivalent |
| K903576 | PUCK 90M | Sep 4, 1990 | Substantially Equivalent |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Aug 21, 1984 | Substantially Equivalent |
| K842911 | PUCK U & UD CUTFILM CHANGERS | Aug 21, 1984 | Substantially Equivalent |
| K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & | Feb 21, 1984 | Substantially Equivalent |
| K790792 | PULSE GENERATOR MODEL 637 | Oct 12, 1979 | Substantially Equivalent |
| K790670 | PULSE GENERATOR MODEL 629 | Jun 27, 1979 | Substantially Equivalent |
| K781178 | PULSE GENERATOR MODEL 208 | Sep 7, 1978 | Substantially Equivalent |
| K770005 | PACEMAKER 208S | Feb 24, 1977 | Substantially Equivalent |
| K770135 | LEAD MODIFICATION | Feb 7, 1977 | Substantially Equivalent |