FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
K Number: K790394
·
Decision Mar 23, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
18
Applicant Total
80
Review Days
25
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Basic Information
- Device Name
- DEFIBRILLATOR INTERAL PADDLE TEST LOAD
- K Number
- K790394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5325
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Physio-Control Corp.
- Date Received
- February 26, 1979
- Decision Date
- March 23, 1979
- Product Code
- DRL
- 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 |
|---|---|---|---|
| DRL | Tester, Defibrillator | FDA class 2 | Cardiovascular |
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Other Clearances by Physio-Control Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K991910 | LIFEPAK 12 BIPHASIC | Sep 3, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | Sep 1, 1999 | Substantially Equivalent |
| K983393 | LIFEPAK 500 BIPHASIC | May 5, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K973486 | LIFE PAK 12 | Jan 9, 1998 | Substantially Equivalent |
| K962359 | LIFEPAK 300 | Nov 6, 1997 | Substantially Equivalent |
| K955854 | LIFEPAK 500 | Nov 4, 1996 | Substantially Equivalent |
| K953204 | PEDIATRIC QUIK-COMBO | Jan 11, 1996 | Substantially Equivalent |
| K951593 | LIFEPAK 11 | Dec 29, 1995 | Substantially Equivalent |
| K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | Sep 26, 1995 | Substantially Equivalent |
| K943301 | QUIK COMBO | Feb 3, 1995 | Substantially Equivalent |