510(k) K840389
- Device
- Sep Programmer Sep-m/single-plane &
- Applicant
- ELEMA-SCHONANDER, INC.
- 510(k) number
- K840389
- Product code
- IZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-21
- Date received
- 1984-01-30
- Regulation
- 892.1870
- Classification name
- Programmer, Changer, Film/Cassette, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014150341
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IZP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934944 | MPQ-42 | Elema-Schonander, Inc. | 1993-12-15 |
| K911888 | PHILIPS ANGIOPRO | Philips Medical Systems North America, Inc. | 1991-10-15 |
| K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | Mallinckrodt Group, Inc. | 1990-12-13 |
| K904103 | SEP 90 | Elema-Schonander, Inc. | 1990-11-20 |
| K874451 | OMNIPLANE 200 FILM CHANGER SYSTEM | Medrad, Inc. | 1988-02-11 |
| K854251 | THE CSE FILM CHANGER SYSTEM | Changer Service & Engineering, Inc. | 1985-10-28 |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Elema-Schonander, Inc. | 1984-08-21 |
| K841649 | MAXIMAX - 4 | Cgr Medical Corp. | 1984-06-05 |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Sybron Corp. | 1984-06-05 |