FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPD COMMANDER
K Number: K974253
·
Decision Feb 25, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
5
Review Days
104
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Basic Information
- Device Name
- CPD COMMANDER
- K Number
- K974253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scieran Technologies, Inc.
- Date Received
- November 13, 1997
- Decision Date
- February 25, 1998
- Product Code
- MRH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
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