510(k) K925581
- Device
- Baxter Biostat 1000 Urea Monitor
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K925581
- Product code
- KXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-03
- Date received
- 1992-11-05
- Regulation
- 876.5820
- Classification name
- System Accessories, Extracorporeal
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- AMY STUEBER
- Address
- 1500 Waukegan Rd. Waukegan IL US 60085 60085
FDA Registration Numbers#
- 2030633