FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROFUSE DUAL RATE INFUSER
K Number: K983321
·
Decision Oct 6, 1998
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
8
Review Days
14
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Basic Information
- Device Name
- MICROFUSE DUAL RATE INFUSER
- K Number
- K983321
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxa Corp.
- Date Received
- September 22, 1998
- Decision Date
- October 6, 1998
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K022523 | RAPID-FILL TUBESET, MODEL 90005 | Aug 12, 2002 | Substantially Equivalent |
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 | Mar 28, 2001 | Substantially Equivalent |
| K951871 | PISTON SYRINGE | Jun 21, 1995 | Substantially Equivalent |
| K933506 | SYRINGE INFUSER | Feb 25, 1994 | Substantially Equivalent |