The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Biospal 2400s.
Device ID | K840812 |
510k Number | K840812 |
Device Name: | BIOSPAL 2400S |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | HOSPAL MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-21 |
Decision Date | 1984-04-02 |