FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K Number: K844214
·
Decision Apr 4, 1985
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
124
Review Days
155
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Basic Information
- Device Name
- COMPARTMENT SYNDROME PRESSURE MONITOR SYS
- K Number
- K844214
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Stryker Corp.
- Date Received
- October 31, 1984
- Decision Date
- April 4, 1985
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXC), ordered by most recent decision date.
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MY01 Continuous Compartmental Pressure Monitor
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Compremium Compartment Compressibility Monitoring System (CPM#1)
FDA 510(k)
FDA Unclassified
·Unknown
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
·Unknown
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
·Unknown
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
·Unknown
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