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 |