FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇴 Norway
Reusable Silicone Cover CPRmeter 2
K Number: K183348
·
Decision Dec 17, 2018
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
16
Applicant Total
3
Review Days
14
Basic Information
- Device Name
- Reusable Silicone Cover CPRmeter 2
- K Number
- K183348
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laerdal Medical AS
- Date Received
- December 3, 2018
- Decision Date
- December 17, 2018
- 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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