FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
K Number: K090961
·
Decision Jun 12, 2009
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
3
Review Days
67
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Basic Information
- Device Name
- TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
- K Number
- K090961
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Twin Star Medical, Inc.
- Date Received
- April 6, 2009
- Decision Date
- June 12, 2009
- Product Code
- LXC
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LXC | Monitor, Pressure, Intracompartmental | FDA unclassified | Unknown |
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