The following data is part of a premarket notification filed by Diametrics Medical, Inc. with the FDA for Irma Blood Analysis System With Optional Lifescan Surestep Pro Blood Glucose Module.
| Device ID | K974396 |
| 510k Number | K974396 |
| Device Name: | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| 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 | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-21 |
| Decision Date | 1997-12-18 |