FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
LIFEPAK 12 DEFIBRILLATOR/MONITOR
K Number: K063510
·
Decision Jan 26, 2007
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
6
Review Days
67
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Basic Information
- Device Name
- LIFEPAK 12 DEFIBRILLATOR/MONITOR
- K Number
- K063510
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Emergency Response Systems, Inc.
- Date Received
- November 20, 2006
- Decision Date
- January 26, 2007
- Product Code
- MKJ
- 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |
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Other Clearances by Medtronic Emergency Response Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR | Dec 22, 2006 | Substantially Equivalent |
| K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | Feb 17, 2006 | Substantially Equivalent |
| K052854 | LIFENET EXCHANGE SYSTEM | Jan 20, 2006 | Substantially Equivalent |
| K042404 | LIFEPAK, MODEL 1000 | Dec 22, 2005 | Substantially Equivalent |
| K041459 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | Jul 1, 2004 | Substantially Equivalent |