FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
LIFEPAK 12
K Number: K040775
·
Decision Apr 23, 2004
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- LIFEPAK 12
- K Number
- K040775
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Physio-Control Corp.
- Date Received
- March 26, 2004
- Decision Date
- April 23, 2004
- 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 Physio-Control Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K033275 | LIFEPAK 12, 20, 500, CR PLUS | Nov 6, 2003 | Substantially Equivalent |
| K022732 | INFANT/CHILD REDUCED ENERGY ELECTRODES | Dec 13, 2002 | Substantially Equivalent |
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER | Feb 5, 2002 | Substantially Equivalent |
| K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR | Dec 3, 2001 | Substantially Equivalent |
| K012428 | MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | Sep 28, 2001 | Substantially Equivalent |
| K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | Aug 23, 2001 | Substantially Equivalent - Subject to Tracking Reg. |
| K002445 | LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES | Jan 31, 2001 | Substantially Equivalent - Subject to Tracking Reg. |