FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SVL-9130 DEFIBRILLATION ELECTRODE
K Number: K971149
·
Decision Jun 23, 1997
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
7
Review Days
87
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Basic Information
- Device Name
- SVL-9130 DEFIBRILLATION ELECTRODE
- K Number
- K971149
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Survivalink Corp.
- Date Received
- March 28, 1997
- Decision Date
- June 23, 1997
- 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 Survivalink Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011901 | FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 | Feb 1, 2002 | Substantially Equivalent |
| K010214 | FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 | Feb 22, 2001 | Substantially Equivalent |
| K993072 | SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) | Dec 10, 1999 | Substantially Equivalent |
| K982264 | FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 | Jan 25, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K970481 | V2 | Jul 1, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K940445 | VIVALINK AED DEFIBRILLATOR | Feb 9, 1995 | Substantially Equivalent |