Irma Blood Analysis System
FDA 510(k) K945240 · Diametrics Medical, Inc.
510(k) numberK945240
Submission
- Device name
- Irma Blood Analysis System
- Applicant
- Diametrics Medical, Inc.
Roseville, MN, US - Received
- October 27, 1994
- Decision date
- January 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBESCHL · Traditional | Radiometer Medicals Aps | 04/10/2026SE |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 05/02/2025SE |
| K240998 | ABL90 FLEX PLUS SystemCHL · Traditional | Radiometer Medicals Aps | 12/13/2024SE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | Nova Biomedical Corporation | 09/29/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 09/15/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | Instrumentation Laboratory Company | 08/10/2023SE |
| K211559 | EasyStat 300CHL · Traditional | Medica Corporation | 01/27/2023SE |
| K203790 | GEM Premier 5000CHL · Special | Instrumentation Laboratory CO | 08/20/2021SE |
| K200986 | OPTI® B-Lac CassetteCHL · Traditional | Opti Medical Systems, Inc. | 08/02/2021SE |
More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030035 | Irma SL Blood Analysis System CR CartridgeJFY · Traditional | 06/25/2003SE |
| K013938 | Irma SL Blood Analysis System Lactate CartridgeKHP · Traditional | 01/28/2002SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | 11/16/2001SE |
| K983198 | Trendcare Calibrator Model Scu 7007CCC · Traditional | 11/23/1999SE |
| K980380 | Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…GWM · Traditional | 07/14/1999SE |
| K981270 | Irma Blood Analysis SystemCGZ · Traditional | 05/01/1998SE |
| K980523 | Irma Blood Analysis System with Optional Multi-Use CartridgeCHL · Traditional | 03/19/1998SE |
| K972314 | Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and…CCC · Traditional | 12/19/1997SE |
| K974396 | Irma Blood Analysis System with Optional Lifescan Surestep Pro Blood Glucose ModuleCHL · Traditional | 12/18/1997SE |
| K970906 | Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus…CBZ · Traditional | 09/23/1997SE |
Questions and answers
When was Irma Blood Analysis System cleared by the FDA?
Irma Blood Analysis System (K945240) received a 510(k) decision of Substantially Equivalent on January 5, 1995, 70 days after the submission was received.
What is the product code of K945240?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.