The following data is part of a premarket notification filed by Diametrics Medical, Inc. with the FDA for Irma Sl Blood Analysis System Gl Cartridge.
| Device ID | K011586 |
| 510k Number | K011586 |
| Device Name: | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | DIAMETRICS MEDICAL, INC. 2658 PATTON RD. Saint Paul, MN 55113 |
| Contact | Nancy Ring |
| Correspondent | Nancy Ring DIAMETRICS MEDICAL, INC. 2658 PATTON RD. Saint Paul, MN 55113 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-23 |
| Decision Date | 2001-11-16 |
| Summary: | summary |