FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BETAFLO 2000 PIGGYBACK SYSTEM
K Number: K864789
·
Decision Feb 4, 1987
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
59
Applicant Total
2
Review Days
58
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Basic Information
- Device Name
- BETAFLO 2000 PIGGYBACK SYSTEM
- K Number
- K864789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Betaflo, Inc.
- Date Received
- December 8, 1986
- Decision Date
- February 4, 1987
- Product Code
- LDR
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LDR | Controller, Infusion, Intravascular, Electronic | FDA class 2 | General Hospital |
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Other Clearances by Betaflo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862273 | BETAFLO 2000 | Jul 18, 1986 | Substantially Equivalent |