FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR RSQ ASSIST
K Number: K123248
·
Decision Dec 10, 2013
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
16
Applicant Total
1
Review Days
419
Basic Information
- Device Name
- CPR RSQ ASSIST
- K Number
- K123248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AVANTECH, INC.
- Date Received
- October 17, 2012
- Decision Date
- December 10, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIX), ordered by most recent decision date.
CPR BAND
FDA 510(k)
FDA Class 2
·Cardiovascular
Reusable Silicone Cover CPRmeter 2
FDA 510(k)
FDA Class 2
·Cardiovascular
CPRmeter 2 CPR Feedback Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Reusable Full Silicone Cover
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUECPR COACHING DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
CPRMETER CPR FEEDBACK DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular