FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
K Number: K982755
·
Decision Aug 20, 1998
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
3
Review Days
52
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Basic Information
- Device Name
- MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
- K Number
- K982755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Blood Management
- Date Received
- June 29, 1998
- Decision Date
- August 20, 1998
- 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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