The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Minnilert(r) Pressure Monitor.
Device ID | K913483 |
510k Number | K913483 |
Device Name: | MINNILERT(R) PRESSURE MONITOR |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Contact | Leroy J Fischbach |
Correspondent | Leroy J Fischbach MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-06 |
Decision Date | 1991-09-27 |