Michigan Instruments
Grand Rapids, MI, US
MICHIGAN INSTRUMENTS appears in FDA device records in Grand Rapids, MI. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Michigan Instruments between 1981 and 2008. The busiest year on record is 1981, with 1. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1983 | 1 |
| 1985 | 1 |
| 1989 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K073079 | THUMPER, MODEL: 1008 | DRM | Substantially Equivalent | |
| K972525 | THUMPER | DRM | Substantially Equivalent | |
| K962237 | THUMPER CARDIOPULMONARY RESUSCITATOR | DRM | Substantially Equivalent | |
| K895954 | LARYNGOSTAT LARYNGOSCOPE HANDLE | CCW | Substantially Equivalent | |
| K851139 | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 | DRM | Substantially Equivalent | |
| K833879 | CARDIOPULMONARY RESUSCITATOR | DRM | Substantially Equivalent | |
| K811909 | CARDIOPULMUNARY RESUSCITATOR | DRM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1821850 | 1821850 | MICHIGAN INSTRUMENTS | 4717 Talon Ct SE, Grand Rapids, MI 49512 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1632-2018 | 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 cases of clinical death as defined by a lack of spontaneous breathing and pulse. | A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last to revolution of the knob could deliver a full 8cm of compression. | Class III | Terminated | |
| Z-0178-2007 | Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000. | Failure to initiate compressions when turned on. | Terminated | ||
| 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 include proper shut down procedures | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain