FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTOFLO
K Number: K020060
·
Decision Mar 5, 2002
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
13
Applicant Total
5
Review Days
56
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Basic Information
- Device Name
- ASTOFLO
- K Number
- K020060
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 864.9205
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nats Corp.
- Date Received
- January 8, 2002
- Decision Date
- March 5, 2002
- Product Code
- BSB
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | FDA class 2 | Hematology |
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