The following data is part of a premarket notification filed by Diametrics Medical, Inc. with the FDA for Irma Blood Analysis System With Optional Multi-use Cartridge.
Device ID | K980523 |
510k Number | K980523 |
Device Name: | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE |
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 |
Subsequent Product Code | CEM |
Subsequent Product Code | GKF |
Subsequent Product Code | JFP |
Subsequent Product Code | JGS |
CFR Regulation Number | 862.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-10 |
Decision Date | 1998-03-19 |