Company ยท US
Michigan Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2008. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 2008 | K073079 | THUMPER, MODEL: 1008 Michigan Instruments, Inc. | DRM |
| Oct 2, 1997 | K972525 | THUMPER Michigan Instruments, Inc. | DRM |
| Sep 5, 1996 | K962237 | THUMPER CARDIOPULMONARY RESUSCITATOR Michigan Instruments, Inc. | DRM |
| Oct 30, 1989 | K895954 | LARYNGOSTAT LARYNGOSCOPE HANDLE Michigan Instruments, Inc. | CCW |
| May 15, 1985 | K851139 | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 Michigan Instruments, Inc. | DRM |
| Dec 27, 1983 | K833879 | CARDIOPULMONARY RESUSCITATOR Michigan Instruments, Inc. | DRM |
| Jul 16, 1981 | K811909 | CARDIOPULMUNARY RESUSCITATOR Michigan Instruments, Inc. | DRM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2018 | Michigan Instruments, Inc. Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370
Product Usage:
The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cas Terminated |
DRM | K972525 |
| Nov 14, 2006 | Michigan Instruments, Inc. Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000. Terminated |
DRM | K972525 |
| Nov 3, 2006 | Michigan Instruments, Inc. Michigan Instruments Thumper Mechanical CPR Device; Model 1007. Terminated |
DRM | K972525 |