FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
K Number: K110645
·
Decision Jun 3, 2011
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
23
Review Days
91
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Basic Information
- Device Name
- BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
- K Number
- K110645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonosite,Inc.
- Date Received
- March 4, 2011
- Decision Date
- June 3, 2011
- Product Code
- DSB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Aug 25, 2008 | Substantially Equivalent |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | May 8, 2007 | Substantially Equivalent |
| K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | Nov 16, 2005 | Substantially Equivalent |
| K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | Aug 11, 2005 | Substantially Equivalent |
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