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
13
Applicant Total
119
Review Days
155
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 |
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