BIOSPAL 2400S

System, Dialysate Delivery, Central Multiple Patient

HOSPAL MEDICAL CORP.

The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Biospal 2400s.

Pre-market Notification Details

Device IDK840812
510k NumberK840812
Device Name:BIOSPAL 2400S
ClassificationSystem, Dialysate Delivery, Central Multiple Patient
Applicant HOSPAL MEDICAL CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFKQ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-21
Decision Date1984-04-02

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