Sep 90
FDA 510(k) K904103 · Elema-Schonander, Inc.
510(k) numberK904103
Submission
- Device name
- Sep 90
- Applicant
- Elema-Schonander, Inc.
Schaumburg, IL, US - Received
- September 6, 1990
- Decision date
- November 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934944 | MPQ-42IZP · Traditional | Elema-Schonander, Inc. | 12/15/1993SE |
| K911888 | Philips AngioproIZP · Traditional | Philips Medical Systems North America, Inc. | 10/15/1991SE |
| K904144 | Pulmovision Chest Radiography X-Ray SystemIZP · Traditional | Mallinckrodt Group, Inc. | 12/13/1990SE |
| K874451 | Omniplane 200 Film Changer SystemIZP · Traditional | Medrad, Inc. | 02/11/1988SE |
| K854251 | The Cse Film Changer SystemIZP · Traditional | Changer Service & Engineering, Inc. | 10/28/1985SE |
| K842903 | Sep Programmer for Puck U & Ud FilmchangIZP · Traditional | Elema-Schonander, Inc. | 08/21/1984SE |
| K841732 | Liebel-Flarsheim Afc 1000 X-Ray FilmIZP · Traditional | Sybron Corp. | 06/05/1984SE |
| K841649 | Maximax - 4IZP · Traditional | Cgr Medical Corp. | 06/05/1984SE |
| K840389 | Sep Programmer Sep-M/Single-Plane &IZP · Traditional | Elema-Schonander, Inc. | 02/21/1984SE |
More from Elema-Schonander, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934944 | MPQ-42IZP · Traditional | 12/15/1993SE |
| K903576 | Puck 90MKPX · Traditional | 09/04/1990SE |
| K842911 | Puck U & Ud Cutfilm ChangersKPX · Traditional | 08/21/1984SE |
| K842903 | Sep Programmer for Puck U & Ud FilmchangIZP · Traditional | 08/21/1984SE |
| K840389 | Sep Programmer Sep-M/Single-Plane &IZP · Traditional | 02/21/1984SE |
| K790792 | Pulse Generator Model 637DXY · Traditional | 10/12/1979SE |
| K790670 | Pulse Generator Model 629DXY · Traditional | 06/27/1979SE |
| K781178 | Pulse Generator Model 208DXY · Traditional | 09/07/1978SE |
| K770005 | Pacemaker 208SDXY · Traditional | 02/24/1977SE |
| K770135 | Lead ModificationDXY · Traditional | 02/07/1977SE |
Questions and answers
When was Sep 90 cleared by the FDA?
Sep 90 (K904103) received a 510(k) decision of Substantially Equivalent on November 20, 1990, 75 days after the submission was received.
What is the product code of K904103?
The FDA product code is IZP – Programmer, Changer, Film/Cassette, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1870.