FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAXTER BIOSTAT 1000 UREA MONITOR
K Number: K925581
·
Decision May 3, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
505
Review Days
909
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Basic Information
- Device Name
- BAXTER BIOSTAT 1000 UREA MONITOR
- K Number
- K925581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corp
- Date Received
- November 5, 1992
- Decision Date
- May 3, 1995
- Product Code
- KXM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KXM | System Accessories, Extracorporeal | FDA class 2 | Gastroenterology, Urology |
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