The following data is part of a premarket notification filed by Diametrics Medical, Inc. with the FDA for Irma Blood Analysis System.
| Device ID | K981270 |
| 510k Number | K981270 |
| Device Name: | IRMA BLOOD ANALYSIS SYSTEM |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | DIAMETRICS MEDICAL, INC. 2658 PATTON RD. Saint Paul, MN 55113 |
| Contact | Steve Boeh |
| Correspondent | Steve Boeh DIAMETRICS MEDICAL, INC. 2658 PATTON RD. Saint Paul, MN 55113 |
| Product Code | CGZ |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GKG |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-07 |
| Decision Date | 1998-05-01 |
| Summary: | summary |