FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THUMPER, MODEL: 1008
K Number: K073079
·
Decision Feb 14, 2008
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
44
Applicant Total
7
Review Days
106
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Basic Information
- Device Name
- THUMPER, MODEL: 1008
- K Number
- K073079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Michigan Instruments, Inc.
- Date Received
- October 31, 2007
- Decision Date
- February 14, 2008
- Product Code
- DRM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRM | Compressor, Cardiac, External | FDA class 2 | Cardiovascular |
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Other Clearances by Michigan Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972525 | THUMPER | Oct 2, 1997 | Substantially Equivalent |
| K962237 | THUMPER CARDIOPULMONARY RESUSCITATOR | Sep 5, 1996 | Substantially Equivalent |
| K895954 | LARYNGOSTAT LARYNGOSCOPE HANDLE | Oct 30, 1989 | Substantially Equivalent |
| K851139 | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 | May 15, 1985 | Substantially Equivalent |
| K833879 | CARDIOPULMONARY RESUSCITATOR | Dec 27, 1983 | Substantially Equivalent |
| K811909 | CARDIOPULMUNARY RESUSCITATOR | Jul 16, 1981 | Substantially Equivalent |