THUMPER
FDA 510(k) clearance K972525 · decided 1997-10-02
Clearance details
- K-number
- K972525
- Device name
- THUMPER
- Applicant
- Michigan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-07
- Decision date
- 1997-10-02
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DRM
- Device class
- 2
- Regulation number
- 870.5200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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| RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (K141809) | Defibtech, LLC | 2014-10-27 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (K112998) | Zoll Circulation | 2012-03-15 |
| MINIATURIZE CHEST COMPRESSOR (MCC) (K102068) | Resuscitation International | 2010-11-16 |
| LUCAS 2 (K090422) | Jolife AB | 2009-06-17 |
| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K072527) | Zoll Circulation | 2008-03-19 |
| THUMPER, MODEL: 1008 (K073079) | Michigan Instruments, Inc. | 2008-02-14 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL100 (K063602) | Zoll Circulation | 2006-12-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000. recall (Z-0178-2007) | Michigan Instruments, Inc. | 2006-11-14 |
| Michigan Instruments Thumper Mechanical CPR Device; Model 1007. recall (Z-0119-2007) | Michigan Instruments, Inc. | 2006-11-03 |