FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSILASE PAD-IQ
K Number: K110438
·
Decision May 4, 2011
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
134
Applicant Total
1
Review Days
78
Basic Information
- Device Name
- SENSILASE PAD-IQ
- K Number
- K110438
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VASAMED, INC.
- Date Received
- February 15, 2011
- Decision Date
- May 4, 2011
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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