Medifette Ergometer
FDA 510(k) K850870 · Ketronic, Inc.
510(k) numberK850870
Submission
- Device name
- Medifette Ergometer
- Applicant
- Ketronic, Inc.
The Netherlands, NL - Received
- March 1, 1985
- Decision date
- June 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Ketronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850877 | Monolift MPE2, Platform, Chair, Fully Futo PlatforILK · Traditional | 06/12/1985SE |
| K850873 | Hilo Tables, Type CH-4, CH-8, FW-6, FW-5, FW-2, AlINO · Traditional | 06/12/1985SE |
| K850869 | Mfe Couch ErgometerISD · Traditional | 06/12/1985SE |
| K850868 | Mfe Cardiac Stress System · Traditional | 06/12/1985SE |
| K850872 | Phyaction 300, 360, 370, 390 & 391 Elec-Muscle-Sti · Traditional | 06/06/1985SN |
| K850871 | Tredband Type I, It, II & III - TreadmillsBXB · Traditional | 06/05/1985SE |
| K850876 | Ligtvoet L80.2 Lightfoot L80.2 Power WheelchairITI · Traditional | 05/16/1985SE |
| K850875 | Action-Wheels & Play Wheels · Traditional | 05/16/1985SE |
| K843288 | Ketronic Medax - NIYX · Traditional | 11/08/1984SE |
Questions and answers
When was Medifette Ergometer cleared by the FDA?
Medifette Ergometer (K850870) received a 510(k) decision of Substantially Equivalent on June 12, 1985, 103 days after the submission was received.