Michigan Instruments, Inc.
Medical device manufacturer in Grand Rapids, MI.
7510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K073079 | Thumper, Model: 1008DRM · Traditional | 02/14/2008SE |
| K972525 | ThumperDRM · Traditional | 10/02/1997SE |
| K962237 | Thumper Cardiopulmonary ResuscitatorDRM · Traditional | 09/05/1996SE |
| K895954 | Laryngostat Laryngoscope HandleCCW · Traditional | 10/30/1989SE |
| K851139 | Thumper Cardiopulmonary Resuscitator 1005DRM · Traditional | 05/15/1985SE |
| K833879 | Cardiopulmonary ResuscitatorDRM · Traditional | 12/27/1983SE |
| K811909 | Cardiopulmunary ResuscitatorDRM · Traditional | 07/16/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1632-2018 Class III | Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage:…A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not… | 02/13/2018Terminated |
| Z-0178-2007 | Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.Failure to initiate compressions when turned on. | 09/14/2006Terminated |
| Z-0119-2007 | Michigan Instruments Thumper Mechanical CPR Device; Model 1007.Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to… | 08/04/2006Terminated |