FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
K Number: K071079
·
Decision Aug 2, 2007
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
1
Review Days
107
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Basic Information
- Device Name
- SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
- K Number
- K071079
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gambro Bct, Inc.
- Date Received
- April 17, 2007
- Decision Date
- August 2, 2007
- Product Code
- LKN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |
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