FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPRMETER CPR FEEDBACK DEVICE
K Number: K122050
·
Decision Oct 22, 2012
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
16
Applicant Total
4
Review Days
102
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Basic Information
- Device Name
- CPRMETER CPR FEEDBACK DEVICE
- K Number
- K122050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laerdal Medical A/S
- Date Received
- July 12, 2012
- Decision Date
- October 22, 2012
- Product Code
- LIX
- 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 |
|---|---|---|---|
| LIX | Aid, Cardiopulmonary Resuscitation | FDA class 2 | Cardiovascular |
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