FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEFIBRILLATOR ANALYZER - DA-2006P
K Number: K110192
·
Decision Feb 8, 2011
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
18
Applicant Total
2
Review Days
15
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Basic Information
- Device Name
- DEFIBRILLATOR ANALYZER - DA-2006P
- K Number
- K110192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5325
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bc Group International, Inc.
- Date Received
- January 24, 2011
- Decision Date
- February 8, 2011
- Product Code
- DRL
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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 Bc Group International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153210 | Defibrillator Analyzer Variable Load | Dec 21, 2015 | Substantially Equivalent |