FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
LIFEPAK 12
K Number: K102972
·
Decision Dec 22, 2010
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
227
Applicant Total
11
Review Days
77
Basic Information
- Device Name
- LIFEPAK 12
- K Number
- K102972
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHYSIO-CONTROL, INC.
- Date Received
- October 6, 2010
- Decision Date
- December 22, 2010
- 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 PHYSIO-CONTROL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K142430 | LIFEPAK 15 monitor/defibrillator | Dec 19, 2014 | Substantially Equivalent |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR | Aug 21, 2013 | Substantially Equivalent |
| K123597 | TRUECPR COACHING DEVICE | Apr 17, 2013 | Substantially Equivalent |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | Oct 11, 2012 | Substantially Equivalent |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Mar 22, 2011 | Substantially Equivalent |
| K102757 | LIFENET SYSTEM | Nov 5, 2010 | Substantially Equivalent |
| K093925 | LIFENET SYSTEM | Jan 12, 2010 | Substantially Equivalent |
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Mar 11, 2009 | Substantially Equivalent |
| K073089 | LIFEPAK 20E | Jul 29, 2008 | Substantially Equivalent |
| K832833 | PERSONAL DEFIBRILLATOR | Oct 26, 1984 | Substantially Equivalent |