FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAR COR SERVICES BICARB SYSTEM
K Number: K003560
·
Decision Jun 8, 2001
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
17
Applicant Total
3
Review Days
203
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Basic Information
- Device Name
- MAR COR SERVICES BICARB SYSTEM
- K Number
- K003560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mar Cor Services, Inc.
- Date Received
- November 17, 2000
- Decision Date
- June 8, 2001
- Product Code
- FIN
- 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 |
|---|---|---|---|
| FIN | Tank, Holding, Dialysis | FDA class 2 | Gastroenterology, Urology |
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