FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSIOFLEX
K Number: K112448
·
Decision Sep 22, 2011
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- PULSIOFLEX
- K Number
- K112448
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pulsion Medical Systems, Inc.
- Date Received
- August 25, 2011
- Decision Date
- September 22, 2011
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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