FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
K Number: K083347
·
Decision Dec 24, 2008
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
18
Applicant Total
6
Review Days
41
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Basic Information
- Device Name
- IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
- K Number
- K083347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5325
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fluke Biomedical
- Date Received
- November 13, 2008
- Decision Date
- December 24, 2008
- 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 Fluke Biomedical
| K Number | Device Name | ||
|---|---|---|---|
| K121860 | ESA615 | Jan 25, 2013 | Substantially Equivalent |
| K121722 | ESA620 ELECTRICAL SAFETY ANALYZER | Oct 11, 2012 | Substantially Equivalent |
| K110429 | PROSIM 4, PROSIM 6, PROSIM 8 | Sep 2, 2011 | Substantially Equivalent |
| K103336 | MPS450 MULTIPARAMETER SIMULATOR | Apr 13, 2011 | Substantially Equivalent |
| K072114 | IMPULSE 6000D/7000DP | Jan 28, 2008 | Substantially Equivalent |