MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT— 510(k) K871218
Substantially EquivalentHospal Medical Corp.
FDA 510(k) clearance K871218 for MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT, Substantially Equivalent on 1987-04-30. Applicant: Hospal Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Hospal Medical Corp.
- Product code
- Code FKP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code FKP
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