FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
FAST-PATCH
K Number: K941970
·
Decision Dec 7, 1994
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
80
Review Days
229
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Basic Information
- Device Name
- FAST-PATCH
- K Number
- K941970
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Physio-Control Corp.
- Date Received
- April 22, 1994
- Decision Date
- December 7, 1994
- 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 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 |