FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cogent Hemodynamic Monitoring System
K Number: K152006
·
Decision May 5, 2016
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
66
Review Days
289
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Basic Information
- Device Name
- Cogent Hemodynamic Monitoring System
- K Number
- K152006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icu Medical, Inc.
- Date Received
- July 21, 2015
- Decision Date
- May 5, 2016
- Product Code
- DXQ
- 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
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