FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOLOG AUTOTRANSFUSION SYSTEM
K Number: K093535
·
Decision Mar 22, 2010
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
209
Review Days
126
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Basic Information
- Device Name
- AUTOLOG AUTOTRANSFUSION SYSTEM
- K Number
- K093535
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- November 16, 2009
- Decision Date
- March 22, 2010
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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