Puck U & Ud Cutfilm Changers
FDA 510(k) K842911 · Elema-Schonander, Inc.
510(k) numberK842911
Submission
- Device name
- Puck U & Ud Cutfilm Changers
- Applicant
- Elema-Schonander, Inc.
Mchenry, IL, US - Received
- July 23, 1984
- Decision date
- August 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945635 | Trans X-1000KPX · Traditional | Canon USA, Inc. | 02/01/1995SE |
| K935157 | Articulated, Laparoscopic, and Side-Viewing T-ProbesKPX · Traditional | Regulatory Consultants TO the Medical Device Indus | 08/09/1994SE |
| K934850 | Nuclear Associates Personnel Protective ShieldsKPX · Traditional | Victoreen, Inc. | 11/22/1993SE |
| K933035 | BCM-600TXKPX · Traditional | B C Medical , Ltd. | 10/08/1993SE |
| K925598 | Buckymatic Automatic Chest Film ChangerKPX · Traditional | Acoma Medical Imaging, Inc. | 02/01/1993SE |
| K924423 | MWX-7440 High Speed BuckyKPX · Traditional | Midwest X-Ray Equipment Co. | 01/15/1993SE |
| K925169 | Shimadzu Radiograpjhic Stand BR-100KPX · Traditional | Shimadzu Medical Systems | 12/03/1992SE |
| K920196 | OX-600KPX · Traditional | Stardard X-Ray Sales Co. | 10/14/1992SE |
| K922483 | Du Pont Compact Daylight System 2000KPX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/11/1992SE |
| K905789 | Franklin 9000 Wall StandKPX · Traditional | Mallinckrodt Group, Inc. | 05/20/1991SE |
More from Mallinckrodt Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934944 | MPQ-42IZP · Traditional | 12/15/1993SE |
| K904103 | Sep 90IZP · Traditional | 11/20/1990SE |
| K903576 | Puck 90MKPX · Traditional | 09/04/1990SE |
| 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 Puck U & Ud Cutfilm Changers cleared by the FDA?
Puck U & Ud Cutfilm Changers (K842911) received a 510(k) decision of Substantially Equivalent on August 21, 1984, 29 days after the submission was received.
What is the product code of K842911?
The FDA product code is KPX – Changer, Radiographic Film/Cassette, a Class II (moderate risk) device regulated under 21 CFR 892.1860.