Irma SL Blood Analysis System GL Cartridge
FDA 510(k) K011586 · Diametrics Medical, Inc.
510(k) numberK011586
Submission
- Device name
- Irma SL Blood Analysis System GL Cartridge
- Applicant
- Diametrics Medical, Inc.
Roseville, MN, US - Received
- May 23, 2001
- Decision date
- November 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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More from Manan Medical Products, 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 |
| 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 |
| K945240 | Irma Blood Analysis SystemCHL · Traditional | 01/05/1995SE |
Questions and answers
When was Irma SL Blood Analysis System GL Cartridge cleared by the FDA?
Irma SL Blood Analysis System GL Cartridge (K011586) received a 510(k) decision of Substantially Equivalent on November 16, 2001, 177 days after the submission was received.
What is the product code of K011586?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.