FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUSION
K Number: K061557
·
Decision Sep 15, 2006
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
5
Review Days
102
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Basic Information
- Device Name
- FUSION
- K Number
- K061557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medwave, Inc.
- Date Received
- June 5, 2006
- Decision Date
- September 15, 2006
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Medwave, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053185 | PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM | Jan 24, 2006 | Substantially Equivalent |
| K011152 | VASOTRAC APM205A | May 31, 2001 | Substantially Equivalent |
| K001898 | VASOTRAX | Aug 31, 2000 | Substantially Equivalent |
| K950249 | VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205 | Feb 1, 1995 | Substantially Equivalent |